Numerics 2.2.7.Opticalrotation26 9.2 2.2.8.Viscosity27 2.2 ... · index europeanpharmacopoeia9.3...

35
EUROPEAN PHARMACOPOEIA 9.3 Index Numerics 1. General notices ............................................................ 9.2-4275 2.1.1. Droppers ........................................................................... 15 2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.1.3. Ultraviolet ray lamps for analytical purposes ............... 15 2.1.4. Sieves ................................................................................. 16 2.1.5. Tubes for comparative tests ............................................ 17 2.1.6. Gas detector tubes ................................................. 9.3-4685 2.1. Apparatus ............................................................................. 15 2.2.10. Viscosity - Rotating viscometer method ..................... 28 2.2.11. Distillation range ........................................................... 30 2.2.12. Boiling point ................................................................... 31 2.2.13. Determination of water by distillation ........................ 31 2.2.14. Melting point - capillary method ...................... 9.1-4037 2.2.15. Melting point - open capillary method ....................... 32 2.2.16. Melting point - instantaneous method........................ 33 2.2.17. Drop point ...................................................................... 33 2.2.18. Freezing point ................................................................. 34 2.2.19. Amperometric titration ................................................. 35 2.2.1. Clarity and degree of opalescence of liquids ..... 9.2-4285 2.2.20. Potentiometric titration ................................................ 35 2.2.21. Fluorimetry ..................................................................... 36 2.2.22. Atomic emission spectrometry .................................... 36 2.2.23. Atomic absorption spectrometry ................................. 37 2.2.24. Absorption spectrophotometry, infrared.................... 39 2.2.25. Absorption spectrophotometry, ultraviolet and visible ......................................................................................... 41 2.2.26. Paper chromatography .................................................. 42 2.2.27. Thin-layer chromatography .......................................... 43 2.2.28. Gas chromatography...................................................... 44 2.2.29. Liquid chromatography................................................. 46 2.2.2. Degree of coloration of liquids ....................................... 22 2.2.30. Size-exclusion chromatography ................................... 47 2.2.31. Electrophoresis ............................................................... 48 2.2.32. Loss on drying ................................................................ 53 2.2.33. Nuclear magnetic resonance spectrometry ................ 54 2.2.34. Thermal analysis ............................................................ 57 2.2.35. Osmolality ....................................................................... 59 2.2.36. Potentiometric determination of ionic concentration using ion-selective electrodes ........................ 60 2.2.37. X-ray fluorescence spectrometry ...................... 9.3-4689 2.2.38. Conductivity ................................................................... 62 2.2.39. Molecular mass distribution in dextrans .................... 62 2.2.3. Potentiometric determination of pH ............................. 24 2.2.40. Near-infrared spectroscopy .......................................... 64 2.2.41. Circular dichroism......................................................... 69 2.2.42. Density of solids ............................................................. 70 2.2.43. Mass spectrometry ......................................................... 71 2.2.44. Total organic carbon in water for pharmaceutical use............................................................................................... 73 2.2.45. Supercritical fluid chromatography ............................. 74 2.2.46. Chromatographic separation techniques ......... 9.2-4286 2.2.47. Capillary electrophoresis............................................... 81 2.2.48. Raman spectroscopy ...................................................... 86 2.2.49. Falling ball and automatic rolling ball viscometer methods .......................................................................... 9.3-4690 2.2.4. Approximate pH of solutions ......................................... 25 2.2.54. Isoelectric focusing ........................................................ 89 2.2.55. Peptide mapping ............................................................ 90 2.2.56. Amino acid analysis ............................................ 9.3-4691 2.2.57. Inductively coupled plasma-atomic emission spectrometry ........................................................................... 100 2.2.58. Inductively coupled plasma-mass spectrometry ...... 101 2.2.59. Glycan analysis of glycoproteins ................................ 103 2.2.5. Relative density................................................................. 25 2.2.61. Characterisation of crystalline solids by microcalorimetry and solution calorimetry........................ 109 2.2.64. Peptide identification by nuclear magnetic resonance spectrometry ........................................................................... 112 2.2.65. Voltametric titration .................................................... 112 2.2.66. Detection and measurement of radioactivity ........... 113 2.2.6. Refractive index................................................................ 26 2.2.7. Optical rotation ................................................................ 26 2.2.8. Viscosity ............................................................................ 27 2.2.9. Capillary viscometer method ......................................... 27 2.2. Physical and physicochemical methods ........................... 21 2.3.1. Identification reactions of ions and functional groups ...................................................................................... 123 2.3.2. Identification of fatty oils by thin-layer chromatography ...................................................................... 126 2.3.3. Identification of phenothiazines by thin-layer chromatography ...................................................................... 127 2.3.4. Odour .............................................................................. 127 2.3. Identification...................................................................... 123 2.4.10. Lead in sugars ............................................................... 136 2.4.11. Phosphates .................................................................... 136 2.4.12. Potassium ...................................................................... 136 2.4.13. Sulfates........................................................................... 136 2.4.14. Sulfated ash ................................................................... 136 2.4.15. Nickel in polyols........................................................... 137 2.4.16. Total ash ........................................................................ 137 2.4.17. Aluminium ................................................................... 137 2.4.18. Free formaldehyde ....................................................... 137 2.4.19. Alkaline impurities in fatty oils .................................. 138 2.4.1. Ammonium .................................................................... 131 2.4.20. Determination of elemental impurities ............ 9.3-4701 2.4.21. Foreign oils in fatty oils by thin-layer chromatography ...................................................................... 141 2.4.22. Composition of fatty acids by gas chromatography.. 141 2.4.23. Sterols in fatty oils ........................................................ 144 2.4.24. Identification and control of residual solvents ......... 146 2.4.25. Ethylene oxide and dioxan .......................................... 151 2.4.26. N,N-Dimethylaniline ................................................... 152 2.4.27. Heavy metals in herbal drugs and herbal drug preparations ............................................................................ 152 2.4.28. 2-Ethylhexanoic acid ................................................... 154 2.4.29. Composition of fatty acids in oils rich in omega-3 acids.......................................................................................... 155 2.4.2. Arsenic............................................................................. 131 2.4.30. Ethylene glycol and diethylene glycol in ethoxylated substances ................................................................................ 157 2.4.31. Nickel in hydrogenated vegetable oils ....................... 157 2.4.32. Total cholesterol in oils rich in omega-3 acids ......... 157 2.4.3. Calcium ........................................................................... 132 2.4.4. Chlorides ......................................................................... 132 2.4.5. Fluorides.......................................................................... 132 2.4.6. Magnesium ..................................................................... 132 2.4.7. Magnesium and alkaline-earth metals ........................ 133 2.4.8. Heavy metals................................................................... 133 2.4.9. Iron .................................................................................. 136 2,4-Dichlorobenzyl alcohol ................................................... 2242 2.4. Limit tests ........................................................................... 131 2.5.10. Oxygen-flask method .................................................. 164 2.5.11. Complexometric titrations.......................................... 164 2.5.12. Water: semi-micro determination ............................. 165 2.5.13. Aluminium in adsorbed vaccines .............................. 165 2.5.14. Calcium in adsorbed vaccines .................................... 166 2.5.15. Phenol in immunosera and vaccines ......................... 166 2.5.16. Protein in polysaccharide vaccines ............................ 166 2.5.17. Nucleic acids in polysaccharide vaccines .................. 166 2.5.18. Phosphorus in polysaccharide vaccines .................... 166 2.5.19. O-Acetyl in polysaccharide vaccines ......................... 167 2.5.1. Acid value........................................................................ 161 2.5.20. Hexosamines in polysaccharide vaccines.................. 167 2.5.21. Methylpentoses in polysaccharide vaccines.............. 167 2.5.22. Uronic acids in polysaccharide vaccines ................... 168 2.5.23. Sialic acid in polysaccharide vaccines ....................... 168 2.5.24. Carbon dioxide in gases .............................................. 168 2.5.25. Carbon monoxide in gases ......................................... 169 2.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 170 2.5.27. Oxygen in gases ............................................................ 170 2.5.28. Water in gases ............................................................... 170 2.5.29. Sulfur dioxide ............................................................... 171 2.5.2. Ester value ....................................................................... 161 2.5.30. Oxidising substances ................................................... 171 General Notices (1) apply to all monographs and other texts 5043

Transcript of Numerics 2.2.7.Opticalrotation26 9.2 2.2.8.Viscosity27 2.2 ... · index europeanpharmacopoeia9.3...

EUROPEAN PHARMACOPOEIA 9.3 Index

Numerics1. General notices ............................................................ 9.2-42752.1.1. Droppers ........................................................................... 152.1.2. Comparative table of porosity of sintered-glass filters.. 152.1.3. Ultraviolet ray lamps for analytical purposes............... 152.1.4. Sieves ................................................................................. 162.1.5. Tubes for comparative tests ............................................ 172.1.6. Gas detector tubes................................................. 9.3-46852.1. Apparatus ............................................................................. 152.2.10. Viscosity - Rotating viscometer method ..................... 282.2.11. Distillation range ........................................................... 302.2.12. Boiling point................................................................... 312.2.13. Determination of water by distillation ........................ 312.2.14. Melting point - capillary method...................... 9.1-40372.2.15. Melting point - open capillary method ....................... 322.2.16. Melting point - instantaneous method........................ 332.2.17. Drop point ...................................................................... 332.2.18. Freezing point................................................................. 342.2.19. Amperometric titration................................................. 352.2.1. Clarity and degree of opalescence of liquids ..... 9.2-42852.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry..................................................................... 362.2.22. Atomic emission spectrometry .................................... 362.2.23. Atomic absorption spectrometry ................................. 372.2.24. Absorption spectrophotometry, infrared.................... 392.2.25. Absorption spectrophotometry, ultraviolet andvisible ......................................................................................... 41

2.2.26. Paper chromatography .................................................. 422.2.27. Thin-layer chromatography.......................................... 432.2.28. Gas chromatography...................................................... 442.2.29. Liquid chromatography................................................. 462.2.2. Degree of coloration of liquids....................................... 222.2.30. Size-exclusion chromatography ................................... 472.2.31. Electrophoresis ............................................................... 482.2.32. Loss on drying................................................................ 532.2.33. Nuclear magnetic resonance spectrometry ................ 542.2.34. Thermal analysis ............................................................ 572.2.35. Osmolality....................................................................... 592.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes ........................ 60

2.2.37. X-ray fluorescence spectrometry ......................9.3-46892.2.38. Conductivity ................................................................... 622.2.39. Molecular mass distribution in dextrans .................... 622.2.3. Potentiometric determination of pH............................. 242.2.40. Near-infrared spectroscopy .......................................... 642.2.41. Circular dichroism......................................................... 692.2.42. Density of solids............................................................. 702.2.43. Mass spectrometry......................................................... 712.2.44. Total organic carbon in water for pharmaceuticaluse............................................................................................... 73

2.2.45. Supercritical fluid chromatography ............................. 742.2.46. Chromatographic separation techniques .........9.2-42862.2.47. Capillary electrophoresis............................................... 812.2.48. Raman spectroscopy...................................................... 862.2.49. Falling ball and automatic rolling ball viscometermethods .......................................................................... 9.3-4690

2.2.4. Approximate pH of solutions ......................................... 252.2.54. Isoelectric focusing ........................................................ 892.2.55. Peptide mapping ............................................................ 902.2.56. Amino acid analysis............................................ 9.3-46912.2.57. Inductively coupled plasma-atomic emissionspectrometry ........................................................................... 100

2.2.58. Inductively coupled plasma-mass spectrometry...... 1012.2.59. Glycan analysis of glycoproteins ................................ 1032.2.5. Relative density................................................................. 252.2.61. Characterisation of crystalline solids bymicrocalorimetry and solution calorimetry........................ 109

2.2.64. Peptide identification by nuclear magnetic resonancespectrometry ........................................................................... 112

2.2.65. Voltametric titration .................................................... 1122.2.66. Detection and measurement of radioactivity ........... 1132.2.6. Refractive index................................................................ 26

2.2.7. Optical rotation ................................................................ 262.2.8. Viscosity ............................................................................ 272.2.9. Capillary viscometer method ......................................... 272.2. Physical and physicochemical methods ........................... 212.3.1. Identification reactions of ions and functionalgroups ...................................................................................... 123

2.3.2. Identification of fatty oils by thin-layerchromatography...................................................................... 126

2.3.3. Identification of phenothiazines by thin-layerchromatography...................................................................... 127

2.3.4. Odour .............................................................................. 1272.3. Identification...................................................................... 1232.4.10. Lead in sugars............................................................... 1362.4.11. Phosphates .................................................................... 1362.4.12. Potassium...................................................................... 1362.4.13. Sulfates........................................................................... 1362.4.14. Sulfated ash ................................................................... 1362.4.15. Nickel in polyols........................................................... 1372.4.16. Total ash ........................................................................ 1372.4.17. Aluminium ................................................................... 1372.4.18. Free formaldehyde ....................................................... 1372.4.19. Alkaline impurities in fatty oils.................................. 1382.4.1. Ammonium .................................................................... 1312.4.20. Determination of elemental impurities............ 9.3-47012.4.21. Foreign oils in fatty oils by thin-layerchromatography...................................................................... 141

2.4.22. Composition of fatty acids by gas chromatography.. 1412.4.23. Sterols in fatty oils........................................................ 1442.4.24. Identification and control of residual solvents ......... 1462.4.25. Ethylene oxide and dioxan.......................................... 1512.4.26. N,N-Dimethylaniline ................................................... 1522.4.27. Heavy metals in herbal drugs and herbal drugpreparations ............................................................................ 152

2.4.28. 2-Ethylhexanoic acid ................................................... 1542.4.29. Composition of fatty acids in oils rich in omega-3acids.......................................................................................... 155

2.4.2. Arsenic............................................................................. 1312.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ................................................................................ 157

2.4.31. Nickel in hydrogenated vegetable oils ....................... 1572.4.32. Total cholesterol in oils rich in omega-3 acids ......... 1572.4.3. Calcium ........................................................................... 1322.4.4. Chlorides ......................................................................... 1322.4.5. Fluorides.......................................................................... 1322.4.6. Magnesium ..................................................................... 1322.4.7. Magnesium and alkaline-earth metals ........................ 1332.4.8. Heavy metals................................................................... 1332.4.9. Iron .................................................................................. 1362,4-Dichlorobenzyl alcohol ................................................... 22422.4. Limit tests........................................................................... 1312.5.10. Oxygen-flask method .................................................. 1642.5.11. Complexometric titrations.......................................... 1642.5.12. Water : semi-micro determination ............................. 1652.5.13. Aluminium in adsorbed vaccines .............................. 1652.5.14. Calcium in adsorbed vaccines .................................... 1662.5.15. Phenol in immunosera and vaccines......................... 1662.5.16. Protein in polysaccharide vaccines ............................ 1662.5.17. Nucleic acids in polysaccharide vaccines .................. 1662.5.18. Phosphorus in polysaccharide vaccines .................... 1662.5.19. O-Acetyl in polysaccharide vaccines ......................... 1672.5.1. Acid value........................................................................ 1612.5.20. Hexosamines in polysaccharide vaccines.................. 1672.5.21. Methylpentoses in polysaccharide vaccines.............. 1672.5.22. Uronic acids in polysaccharide vaccines ................... 1682.5.23. Sialic acid in polysaccharide vaccines ....................... 1682.5.24. Carbon dioxide in gases .............................................. 1682.5.25. Carbon monoxide in gases ......................................... 1692.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 1702.5.27. Oxygen in gases............................................................ 1702.5.28. Water in gases............................................................... 1702.5.29. Sulfur dioxide ............................................................... 1712.5.2. Ester value....................................................................... 1612.5.30. Oxidising substances ................................................... 171

General Notices (1) apply to all monographs and other texts 5043

Index EUROPEAN PHARMACOPOEIA 9.3

2.5.31. Ribose in polysaccharide vaccines ............................. 1712.5.32. Water : micro determination....................................... 1722.5.33. Total protein ................................................................. 1722.5.34. Acetic acid in synthetic peptides................................ 1752.5.35. Nitrous oxide in gases ................................................. 1762.5.36. Anisidine value............................................................. 1762.5.37. Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid ............................................................. 176

2.5.38. Methyl, ethyl and isopropyl methanesulfonate in activesubstances ................................................................................ 177

2.5.39. Methanesulfonyl chloride in methanesulfonicacid ........................................................................................... 178

2.5.3. Hydroxyl value ............................................................... 1612.5.40. Methyl, ethyl and isopropyl toluenesulfonate in activesubstances ................................................................................ 179

2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in activesubstances ................................................................................ 180

2.5.4. Iodine value .................................................................... 1612.5.5. Peroxide value................................................................. 1622.5.6. Saponification value....................................................... 1632.5.7. Unsaponifiable matter ................................................... 1632.5.8. Determination of primary aromatic amino-nitrogen.................................................................................... 163

2.5.9. Determination of nitrogen by sulfuric aciddigestion .................................................................................. 164

2.5. Assays ................................................................................. 1612.6.10. Histamine...................................................................... 1942.6.11. Depressor substances................................................... 1952.6.12. Microbiological examination of non-sterile products :microbial enumeration tests.................................................. 195

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ....................................... 199

2.6.14. Bacterial endotoxins ........................................... 9.3-47072.6.15. Prekallikrein activator ................................................. 2082.6.16. Tests for extraneous agents in viral vaccines for humanuse.................................................................................... 9.3-4711

2.6.17. Test for anticomplementary activity ofimmunoglobulin............................................................ 9.3-4713

2.6.18. Test for neurovirulence of live virus vaccines .......... 2122.6.1. Sterility ............................................................................ 1852.6.20. Anti-A and anti-B haemagglutinins .......................... 2132.6.21. Nucleic acid amplification techniques....................... 2142.6.22. Activated coagulation factors ..................................... 2192.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ................................................................................... 219

2.6.25. Avian live virus vaccines : tests for extraneous agents inbatches of finished product ................................................... 222

2.6.26. Test for anti-D antibodies in human immunoglobu-lin.............................................................................................. 225

2.6.27. Microbiological examination of cell-basedpreparations ................................................................... 9.2-4297

2.6.2. Mycobacteria .................................................................. 1882.6.30. Monocyte-activation test.................................... 9.2-42992.6.31. Microbiological examination of herbal medicinalproducts for oral use and extracts used in theirpreparation .............................................................................. 232

2.6.33. Residual pertussis toxin and irreversibility of pertussistoxoid ....................................................................................... 235

2.6.34. Host-cell protein assays...................................... 9.1-40412.6.7. Mycoplasmas .................................................................. 1882.6.8. Pyrogens.......................................................................... 1932.6.9. Abnormal toxicity .......................................................... 1942.6. Biological tests ................................................................... 1852.7.10. Assay of human coagulation factor VII .................... 2582.7.11. Assay of human coagulation factor IX ...................... 2592.7.12. Assay of heparin in coagulation factors .................... 2592.7.13. Assay of human anti-D immunoglobulin ................. 2602.7.14. Assay of hepatitis A vaccine ....................................... 2622.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 2632.7.16. Assay of pertussis vaccine (acellular) ........................ 2632.7.17. Assay of human antithrombin III .............................. 2652.7.18. Assay of human coagulation factor II ....................... 2662.7.19. Assay of human coagulation factor X........................ 266

2.7.1. Immunochemical methods........................................... 2392.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 2672.7.21. Assay of human von Willebrand factor..................... 2682.7.22. Assay of human coagulation factor XI ...................... 2692.7.23. Numeration of CD34/CD45+ cells inhaematopoietic products ....................................................... 269

2.7.24. Flow cytometry ............................................................ 2712.7.25. Assay of human plasmin inhibitor............................. 2722.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) ................................................... 273

2.7.28. Colony-forming cell assay for humanhaematopoietic progenitor cells............................................ 274

2.7.29. Nucleated cell count and viability.............................. 2752.7.2. Microbiological assay of antibiotics.................... 9.3-47192.7.30. Assay of human protein C .......................................... 2762.7.31. Assay of human protein S ........................................... 2772.7.32. Assay of human α-1-proteinase inhibitor ................. 2782.7.34. Assay of human C1-esterase inhibitor ...................... 2782.7.35. Immunonephelometry for vaccine componentassay ......................................................................................... 279

2.7.4. Assay of human coagulation factor VIII ..................... 2462.7.5. Assay of heparin.................................................... 9.1-40492.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 2472.7.7. Assay of pertussis vaccine (whole cell)........................ 2522.7.8. Assay of tetanus vaccine (adsorbed)............................ 2532.7.9. Test for Fc function of immunoglobulin............ 9.3-47242.7. Biological assays ................................................................ 2392.8.10. Solubility in alcohol of essential oils.......................... 2842.8.11. Assay of 1,8-cineole in essential oils.......................... 2852.8.12. Essential oils in herbal drugs...................................... 2852.8.13. Pesticide residues ......................................................... 2862.8.14. Tannins in herbal drugs .............................................. 2882.8.15. Bitterness value............................................................. 2882.8.16. Dry residue of extracts ................................................ 2892.8.17. Loss on drying of extracts........................................... 2892.8.18. Determination of aflatoxin B1 in herbal drugs ......... 2892.8.1. Ash insoluble in hydrochloric acid .............................. 2832.8.20. Herbal drugs : sampling and sample preparation .... 2912.8.21. Test for aristolochic acids in herbal drugs ................ 2922.8.22. Determination of ochratoxin A in herbal drugs ...... 2942.8.23. Microscopic examination of herbal drugs ................ 2952.8.25. High-performance thin-layer chromatography ofherbal drugs and herbal drug preparations ........................ 295

2.8.2. Foreign matter ................................................................ 2832.8.3. Stomata and stomatal index.......................................... 2832.8.4. Swelling index................................................................. 2842.8.5. Water in essential oils .................................................... 2842.8.6. Foreign esters in essential oils ...................................... 2842.8.7. Fatty oils and resinified essential oils in essentialoils ............................................................................................ 284

2.8.8. Odour and taste of essential oils .................................. 2842.8.9. Residue on evaporation of essential oils ..................... 2842.8. Methods in pharmacognosy ............................................ 2832.9.10. Ethanol content ............................................................ 3152.9.11. Test for methanol and 2-propanol ............................. 3182.9.12. Sieve test........................................................................ 3192.9.14. Specific surface area by air permeability.......... 9.1-40532.9.16. Flowability..................................................................... 3212.9.17. Test for extractable volume of parenteralpreparations ............................................................................ 322

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles........................................................................ 323

2.9.19. Particulate contamination : sub-visible particles...... 3352.9.1. Disintegration of tablets and capsules ......................... 2992.9.20. Particulate contamination : visible particles ............. 3372.9.22. Softening time determination of lipophilicsuppositories ........................................................................... 338

2.9.23. Gas pycnometric density of solids ............................. 3392.9.25. Dissolution test for medicated chewing gums ......... 3402.9.26. Specific surface area by gas adsorption ..................... 3442.9.27. Uniformity of mass of delivered doses from multidosecontainers ................................................................................ 347

2.9.29. Intrinsic dissolution..................................................... 347

5044 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

2.9.2. Disintegration of suppositories and pessaries ............ 3012.9.31. Particle size analysis by laser light diffraction.......... 3492.9.32. Porosity and pore-size distribution of solids bymercury porosimetry ............................................................. 352

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD) ....................... 354

2.9.34. Bulk density and tapped density of powders............ 3592.9.35. Powder fineness............................................................ 3622.9.36. Powder flow .................................................................. 3622.9.37. Optical microscopy...................................................... 3652.9.38. Particle-size distribution estimation by analyticalsieving ...................................................................................... 367

2.9.39. Water-solid interactions : determination ofsorption-desorption isotherms and of water activity......... 369

2.9.3. Dissolution test for solid dosage forms ....................... 3022.9.40. Uniformity of dosage units ................................ 9.1-40552.9.41. Friability of granules and spheroids .......................... 3752.9.42. Dissolution test for lipophilic solid dosage forms ... 3772.9.43. Apparent dissolution ................................................... 3772.9.44. Preparations for nebulisation : characterisation....... 3782.9.45. Wettability of porous solids including powders....... 3812.9.47. Demonstration of uniformity of dosage units usinglarge sample sizes.................................................................... 384

2.9.4. Dissolution test for transdermal patches .................... 3092.9.5. Uniformity of mass of single-dose preparations ........ 3112.9.6. Uniformity of content of single-dose preparations.... 3122.9.7. Friability of uncoated tablets ........................................ 3122.9.8. Resistance to crushing of tablets .................................. 3132.9.9. Measurement of consistency by penetrometry .......... 3132.9. Pharmaceutical technical procedures ............................. 2993.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions......... 410

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for solid dosage forms for oraladministration......................................................................... 412

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components......... 391

3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents ............................................................................. 393

3.1.13. Plastic additives ............................................................ 4143.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion .................................................................................... 416

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use ...................................... 419

3.1.1. Materials for containers for human blood and bloodcomponents ............................................................................. 391

3.1.3. Polyolefins .............................................................. 9.2-43073.1.4. Polyethylene without additives for containersfor parenteral preparations and for ophthalmicpreparations ................................................................... 9.2-4310

3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations .......... 9.2-4311

3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations ................ 9.2-4314

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations ................. 9.2-4318

3.1.8. Silicone oil used as a lubricant ..................................... 4083.1.9. Silicone elastomer for closures and tubing ................. 4093.1. Materials used for the manufacture of containers ........ 3913.2.1. Glass containers for pharmaceutical use..................... 4233.2.2.1. Plastic containers for aqueous solutions forinfusion .................................................................................... 429

3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................. 428

3.2.3. Sterile plastic containers for human blood andblood components .................................................................. 430

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components........... 432

3.2.5. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ............... 432

3.2.6. Sets for the transfusion of blood and bloodcomponents ............................................................................. 433

3.2.8. Sterile single-use plastic syringes ................................. 4343.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders.............................................................. 435

3.2. Containers.......................................................................... 4233-O-Desacyl-4-monophosphoryl lipid A............................ 22074.1.1. Reagents .......................................................................... 4414.1.1. Reagents .................................................................9.1-40614.1.1. Reagents ................................................................. 9.2-43234.1.1. Reagents ................................................................. 9.3-47294.1.2. Standard solutions for limit tests ................................. 5554.1.2. Standard solutions for limit tests ........................ 9.2-43244.1.2. Standard solutions for limit tests ........................ 9.3-47304.1.3. Buffer solutions .............................................................. 5604.1.3. Buffer solutions ..................................................... 9.1-40614.1.3. Buffer solutions ..................................................... 9.2-43244.1.3. Buffer solutions ..................................................... 9.3-47304.1. Reagents, standard solutions, buffer solutions .............. 4414.2.1. Primary standards for volumetric solutions ...... 9.2-43244.2.2. Volumetric solutions............................................. 9.2-43254.2.2. Volumetric solutions............................................. 9.3-47304.2. Volumetric analysis........................................................... 5654-Aminobenzoic acid ............................................................. 17024. Reagents................................................................................. 4415.10. Control of impurities in substances for pharmaceuticaluse............................................................................................. 723

5.1.10. Guidelines for using the test for bacterialendotoxins ............................................................................... 593

5.1.11. Determination of bactericidal, fungicidal or yeasticidalactivity of antiseptic medicinal products.................... 9.2-4348

5.11. Characters section in monographs ............................... 7295.1.1. Methods of preparation of sterile products ....... 9.2-43335.1.2. Biological indicators and related microbial preparationsused in the manufacture of sterile products............... 9.2-4336

5.12. Reference standards ........................................................ 7335.1.3. Efficacy of antimicrobial preservation ........................ 5775.14. Gene transfer medicinal products for human use ...... 7395.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use......... 579

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ............................................................. 580

5.15. Functionality-related characteristics ofexcipients ........................................................................ 9.2-4411

5.1.6. Alternative methods for control of microbiologicalquality ............................................................................. 9.2-4339

5.16. Crystallinity ..................................................................... 7575.17.1. Recommendations on dissolution testing................. 7615.17. Recommendations on methods for dosage formstesting....................................................................................... 761

5.1.7. Viral safety ...................................................................... 5915.1.8. Microbiological quality of herbal medicinal products fororal use and extracts used in their preparation .................. 591

5.19. Extemporaneous preparation of radiopharmaceuti-cals ............................................................................................ 767

5.1.9. Guidelines for using the test for sterility..................... 5925.1. General texts on microbiology ........................................ 5755.20. Elemental impurities ............................................. 9.3-47595.2.11. Carrier proteins for the production of conjugatedpolysaccharide vaccines for human use............................... 626

5.2.12. Raw materials of biological origin for the productionof cell-based and gene therapy medicinal products ........... 627

5.2.13. Healthy chicken flocks for the production of inactivatedvaccines for veterinary use .................................................... 630

5.2.14. Substitution of in vivo method(s) by in vitromethod(s)for the quality control of vaccines ............................... 9.3-4737

5.21. Chemometric methods applied to analytical data ...... 7835.2.1. Terminology used in monographs on biologicalproducts ................................................................................... 599

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines......................... 599

General Notices (1) apply to all monographs and other texts 5045

Index EUROPEAN PHARMACOPOEIA 9.3

5.22. Names of herbal drugs used in traditional Chinesemedicine ......................................................................... 9.3-4763

5.2.3. Cell substrates for the production of vaccines for humanuse.................................................................................... 9.3-4733

5.23. Monographs on herbal drug extracts (informationchapter) .................................................................................... 807

5.2.4. Cell cultures for the production of veterinaryvaccines .................................................................................... 606

5.24. Chemical imaging .................................................. 9.3-47675.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products .................. 608

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ........................................................................... 610

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera ............................................................................ 612

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ................................................................................... 613

5.2.9. Evaluation of safety of each batch of immunosera forveterinary use.......................................................................... 625

5.2. General texts on biological products .............................. 5995.3. Statistical analysis of results of biological assays andtests.................................................................................. 9.2-4353

5.4. Residual solvents ............................................................... 6655.5. Alcoholimetric tables........................................................ 6755.6. Assay of interferons .......................................................... 6895.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia ............. 9.2-4385

5.8. Pharmacopoeial harmonisation ............................. 9.3-47415.9. Polymorphism ................................................................... 719

AAbacavir sulfate....................................................................... 1619Abbreviations and symbols (1.) ..................................... 9.2-4275Abnormal toxicity (2.6.9.)........................................................ 194Absorption spectrophotometry, infrared (2.2.24.) ................. 39Absorption spectrophotometry, ultraviolet and visible(2.2.25.) ...................................................................................... 41

Acacia ....................................................................................... 1229Acacia, spray-dried ................................................................. 1620Acamprosate calcium ............................................................. 1621Acanthopanax bark ......................................................... 9.2-4447Acarbose .................................................................................. 1622Acebutolol hydrochloride ...................................................... 1624Aceclofenac....................................................................... 9.3-4835Acemetacin .............................................................................. 1628Acesulfame potassium............................................................ 1629Acetate trihydrate, sodium .................................................... 3558Acetazolamide......................................................................... 1630Acetic acid, glacial .................................................................. 1632Acetic acid in synthetic peptides (2.5.34.) ............................. 175Acetone .................................................................................... 1632Acetylcholine chloride ........................................................... 1633Acetylcysteine.......................................................................... 1634β-Acetyldigoxin....................................................................... 1635Acetylene intermix (1 per cent) in nitrogen................. 9.3-4836Acetylsalicylic acid ................................................................. 1638Acetyltryptophan, N- ............................................................. 1639Acetyltyrosine, N- ................................................................... 1641Aciclovir................................................................................... 1642Acidum picrinicum for homoeopathic preparations ......... 1587Acid value (2.5.1.) ..................................................................... 161Acitretin ................................................................................... 1644Actinobacillosis vaccine (inactivated), porcine .................. 1085Activated charcoal .................................................................. 2025Activated coagulation factors (2.6.22.)................................... 219Adapalene ................................................................................ 1646Additives, plastic (3.1.13.) ....................................................... 414Adenine.................................................................................... 1647Adeno-associated-virus vectors for human use .................... 748Adenosine ................................................................................ 1648Adenovirus vaccine (inactivated), canine............................ 1027

Adenovirus vaccine (live), canine......................................... 1028Adipic acid............................................................................... 1649Adrenaline ............................................................................... 1650Adrenaline tartrate ................................................................. 1652Adsorption, gas, specific surface area by (2.9.26.)................ 344Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) ................................................................. 323

Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 289Agar .......................................................................................... 1230Agaricus phalloides for homoeopathic preparations ......... 1588Agnus castus fruit ................................................................... 1231Agnus castus fruit dry extract ............................................... 1232Agrimony................................................................................. 1233Air, medicinal ......................................................................... 1653Air, synthetic medicinal......................................................... 1655Akebia stem ............................................................................. 1234Alanine..................................................................................... 1656Albendazole............................................................................. 1657Albumin solution, human ..................................................... 2660Alchemilla................................................................................ 1235Alcoholimetric tables (5.5.) ..................................................... 675Alcuronium chloride.............................................................. 1658Alendronate trihydrate, sodium ........................................... 3559Alexandrian senna pods ........................................................ 1518Alfacalcidol.............................................................................. 1660Alfadex .............................................................................. 9.3-4838Alfentanil hydrochloride ....................................................... 1662Alfuzosin hydrochloride ................................................. 9.1-4123Alginate, sodium..................................................................... 3560Alginic acid.............................................................................. 1665Alimemazine hemitartrate..................................................... 1666Alkaline-earth metals and magnesium (2.4.7.)..................... 133Alkaline impurities in fatty oils (2.4.19.) ............................... 138Allantoin .................................................................................. 1667Allergen products ..................................................................... 811Allergen products, animal epithelia and outgrowths for... 1736Allergen products, Hymenoptera venoms for..................... 2732Allergen products, mites for.................................................. 3077Allergen products, moulds for .............................................. 3094Allergen products, pollens for............................................... 3362Allium sativum for homoeopathic preparations ................ 1590Allopurinol .............................................................................. 1668all-rac-α-Tocopherol............................................................... 3800all-rac-α-Tocopheryl acetate.................................................. 3802Almagate .................................................................................. 1670Almond oil, refined ................................................................ 1671Almond oil, virgin .................................................................. 1671Aloes, Barbados ...................................................................... 1236Aloes, Cape.............................................................................. 1237Aloes dry extract, standardised............................................. 1238Alovudine (18F) injection ....................................................... 1127Alphacyclodextrin ........................................................... 9.3-4838Alprazolam .............................................................................. 1672Alprenolol hydrochloride ...................................................... 1674Alprostadil ............................................................................... 1675Alteplase for injection ............................................................ 1677Alternative methods for control of microbiological quality(5.1.6.) ............................................................................. 9.2-4339

Altizide..................................................................................... 1681Alum......................................................................................... 1682Aluminium (2.4.17.)................................................................. 137Aluminium chloride hexahydrate......................................... 1682Aluminium hydroxide, hydrated, for adsorption ............... 1682Aluminium in adsorbed vaccines (2.5.13.)............................ 165Aluminium magnesium silicate ..................................... 9.3-4839Aluminium oxide, hydrated .................................................. 1684Aluminium phosphate gel ..................................................... 1685Aluminium phosphate, hydrated.......................................... 1686Aluminium sodium silicate ................................................... 1686Aluminium stearate................................................................ 1687Aluminium sulfate.................................................................. 1689Alverine citrate................................................................. 9.3-4841Amantadine hydrochloride ................................................... 1691

5046 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Ambroxol hydrochloride ................................................ 9.2-4499Amfetamine sulfate ................................................................ 1694Amidotrizoate, sodium .......................................................... 3561Amidotrizoic acid dihydrate ................................................. 1694Amikacin ................................................................................. 1696Amikacin sulfate ..................................................................... 1698Amiloride hydrochloride dihydrate .............................. 9.2-4500Amino acid analysis (2.2.56.) ......................................... 9.3-4691Aminobenzoic acid, 4- ........................................................... 1702Aminocaproic acid ................................................................. 1703Aminoglutethimide ................................................................ 1704Aminophylline ........................................................................ 3752Aminophylline hydrate .......................................................... 3754Aminosalicylate dihydrate, sodium...................................... 3562Amiodarone hydrochloride................................................... 1706Amisulpride............................................................................. 1707Amitriptyline hydrochloride ................................................. 1709Amlodipine besilate................................................................ 1710Ammonia (13N) injection....................................................... 1129Ammonia solution, concentrated ......................................... 1712Ammonio methacrylate copolymer (type A)...................... 1712Ammonio methacrylate copolymer (type B) ...................... 1713Ammonium (2.4.1.).................................................................. 131Ammonium bromide ............................................................. 1714Ammonium carbonicum for homoeopathic preparations.. 9.3-4827

Ammonium chloride.............................................................. 1715Ammonium glycyrrhizate ..................................................... 1716Ammonium hydrogen carbonate ......................................... 1717Amobarbital ............................................................................ 1717Amobarbital sodium .............................................................. 1718Amomum fruit........................................................................ 1239Amomum fruit, round ........................................................... 1502Amorolfine hydrochloride..................................................... 1719Amoxicillin sodium................................................................ 1720Amoxicillin trihydrate............................................................ 1723Amperometric titration (2.2.19.) .............................................. 35Amphotericin B ...................................................................... 1725Ampicillin ................................................................................ 1727Ampicillin sodium.................................................................. 1729Ampicillin trihydrate.............................................................. 1731Amylmetacresol ...................................................................... 1733Anacardium for homoeopathic preparations...................... 1591Anaemia vaccine (live), chicken, infectious ........................ 1069Anaesthetic ether .................................................................... 2422Analysis, thermal (2.2.34.)......................................................... 57Analytical sieving, particle-size distribution estimation by(2.9.38.) .................................................................................... 367

Anamirta cocculus for homoeopathic preparations .......... 1597Anastrozole....................................................................... 9.3-4842Andrographis herb .......................................................... 9.3-4807Anemarrhena asphodeloides rhizome ................................. 1241Angelica archangelica root .................................................... 1242Angelica dahurica root.................................................... 9.3-4808Angelica pubescens root ................................................. 9.3-4810Angelica sinensis root ..................................................... 9.1-4100Animal anti-T lymphocyte immunoglobulin for humanuse........................................................................................... 1741

Animal epithelia and outgrowths for allergen products.... 1736Animal immunosera for human use ...................................... 821Animal spongiform encephalopathies, products with risk oftransmitting agents of ............................................................ 832

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.)...................................................................... 613

Aniseed ............................................................................. 9.2-4448Anise oil ................................................................................... 1248Anisidine value (2.5.36.) .......................................................... 176Antazoline hydrochloride...................................................... 1737Anthrax spore vaccine (live) for veterinary use.................. 1003Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates)....................................................................... 893

Anti-A and anti-B haemagglutinins (2.6.20.)........................ 213

Antibiotics, microbiological assay of (2.7.2.) ............... 9.3-4719Antibodies (anti-D) in human immunoglobulin, test for(2.6.26.) .................................................................................... 225

Antibodies for human use, monoclonal ................................ 826Anticoagulant and preservative solutions for human blood................................................................................................ 1738

Anticomplementary activity of immunoglobulin(2.6.17.) ........................................................................... 9.3-4713

Anti-D antibodies in human immunoglobulin, test for(2.6.26.) .................................................................................... 225

Anti-D immunoglobulin for intravenous administration,human .................................................................................... 2663

Anti-D immunoglobulin, human ......................................... 2662Anti-D immunoglobulin, human, assay of (2.7.13.) ............ 260Antimicrobial preservation, efficacy of (5.1.3.) .................... 577Antiseptic medicinal products, determination of bactericidal,fungicidal or yeasticidal activity of (5.1.11.) .............. 9.2-4348

Antiserum, European viper venom ...................................... 1119Antithrombin III concentrate, human................................. 2664Antithrombin III, human, assay of (2.7.17.) ......................... 265Anti-T lymphocyte immunoglobulin for human use,animal .................................................................................... 1741

Apis for homoeopathic preparations.................................... 1592Apomorphine hydrochloride hemihydrate ......................... 1744Apparatus (2.1.) .......................................................................... 15Apparent dissolution (2.9.43.)................................................. 377Application of the F0 concept to steam sterilisation of aqueouspreparations (5.1.5.) ............................................................... 580

Approximate pH of solutions (2.2.4.)....................................... 25Aprepitant................................................................................ 1746Aprotinin ................................................................................. 1747Aprotinin concentrated solution .......................................... 1749Arachis oil, hydrogenated...................................................... 1752Arachis oil, refined ................................................................. 1752Arginine ................................................................................... 1753Arginine aspartate .................................................................. 1754Arginine hydrochloride ......................................................... 1755Argon ....................................................................................... 1756Aripiprazole............................................................................. 1757Aristolochic acids in herbal drugs, test for (2.8.21) ............. 292Arnica flower........................................................................... 1251Arnica tincture........................................................................ 1253Arsenic (2.4.2.) .......................................................................... 131Arsenicum album for homoeopathic preparations ............ 1593Arsenious trioxide for homoeopathic preparations ........... 1593Articaine hydrochloride......................................................... 1758Artichoke leaf .......................................................................... 1254Artichoke leaf dry extract ...................................................... 1256Ascorbate, calcium ................................................................. 1911Ascorbate, sodium.................................................................. 3563Ascorbic acid .................................................................... 9.3-4843Ascorbyl palmitate.................................................................. 1762Ash insoluble in hydrochloric acid (2.8.1.) ........................... 283Ash leaf .................................................................................... 1257Ash, sulfated (2.4.14.)............................................................... 136Ash, total (2.4.16.) .................................................................... 137Asparagine monohydrate....................................................... 1762Aspartame................................................................................ 1763Aspartic acid..................................................................... 9.3-4845Assay of 1,8-cineole in essential oils (2.8.11.) ....................... 285Assay of diphtheria vaccine (adsorbed) (2.7.6.).................... 247Assay of heparin (2.7.5.) ................................................. 9.1-4049Assay of heparin in coagulation factors (2.7.12.) ................. 259Assay of hepatitis A vaccine (2.7.14.)..................................... 262Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 263Assay of human α-1-proteinase inhibitor (2.7.32.) .............. 278Assay of human anti-D immunoglobulin (2.7.13.) .............. 260Assay of human antithrombin III (2.7.17.)............................ 265Assay of human C1-esterase inhibitor (2.7.34.).................... 278Assay of human coagulation factor II (2.7.18.)..................... 266Assay of human coagulation factor IX (2.7.11.) ................... 259Assay of human coagulation factor VII (2.7.10.).................. 258Assay of human coagulation factor VIII (2.7.4.) .................. 246

General Notices (1) apply to all monographs and other texts 5047

Index EUROPEAN PHARMACOPOEIA 9.3

Assay of human coagulation factor X (2.7.19.) ..................... 266Assay of human coagulation factor XI (2.7.22.) ................... 269Assay of human plasmin inhibitor (2.7.25.) .......................... 272Assay of human protein C (2.7.30.)........................................ 276Assay of human protein S (2.7.31.) ........................................ 277Assay of human von Willebrand factor (2.7.21.) .................. 268Assay of interferons (5.6.)........................................................ 689Assay of pertussis vaccine (acellular) (2.7.16.)...................... 263Assay of pertussis vaccine (whole cell) (2.7.7.) ..................... 252Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .................................................................................... 267

Assay of tetanus vaccine (adsorbed) (2.7.8.) ......................... 253Assays (2.5.)............................................................................... 161Astragalus mongholicus root ......................................... 9.2-4449Atenolol............................................................................. 9.1-4124Atomic absorption spectrometry (2.2.23.) .............................. 37Atomic emission spectrometry (2.2.22.).................................. 36Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) .................................................................................... 100

Atomoxetine hydrochloride .................................................. 1767Atorvastatin calcium trihydrate ............................................ 1769Atovaquone.............................................................................. 1771Atractylodes lancea rhizome ................................................. 1259Atractylodes rhizome, largehead .......................................... 1260Atracurium besilate ................................................................ 1772Atropine ............................................................................9.3-4847Atropine sulfate................................................................ 9.3-4849Aucklandia root ............................................................... 9.2-4450Aujeszky’s disease vaccine (inactivated) for pigs ................ 1003Aujeszky’s disease vaccine (live) for pigs for parenteraladministration....................................................................... 1005

Aurothiomalate, sodium........................................................ 3565Aurum chloratum natronatum for homoeopathicpreparations .......................................................................... 1593

Automatic rolling ball and falling ball viscometer methods(2.2.49.) ...........................................................................9.3-4690

Avian infectious bronchitis vaccine (inactivated)............... 1007Avian infectious bronchitis vaccine (live)............................ 1008Avian infectious bursal disease vaccine (inactivated) ........ 1010Avian infectious bursal disease vaccine (live) ..................... 1011Avian infectious encephalomyelitis vaccine (live) .............. 1013Avian infectious laryngotracheitis vaccine (live)................ 1014Avian live virus vaccines : tests for extraneous agents in batchesof finished product (2.6.25.).................................................. 222

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .......................................................................... 1080

Avian paramyxovirus 1 (Newcastle disease) vaccine(live) ....................................................................................... 1082

Avian paramyxovirus 3 vaccine (inactivated) for turkeys.. 1016Avian tuberculin purified protein derivative....................... 3862Avian viral tenosynovitis vaccine (live) ............................... 1017Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) .................................................................................... 219

Azaperone for veterinary use ................................................ 1778Azathioprine............................................................................ 1779Azelastine hydrochloride ....................................................... 1780Azithromycin ................................................................... 9.3-4850

BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines..................................................................... 214

Bacampicillin hydrochloride ................................................. 1787Bacitracin.......................................................................... 9.1-4129Bacitracin zinc.................................................................. 9.1-4133Baclofen ................................................................................... 1794Bacterial endotoxins (2.6.14.)......................................... 9.3-4707Bacterial endotoxins, guidelines for using the test for(5.1.10.) .................................................................................... 593

Bactericidal, fungicidal or yeasticidal activity of antisepticmedicinal products, determination of (5.1.11.) ......... 9.2-4348

Baical skullcap root ................................................................ 1262

Bambuterol hydrochloride .................................................... 1795Barbados aloes ........................................................................ 1236Barbary wolfberry fruit................................................... 9.3-4812Barbital..................................................................................... 1797Barium chloratum for homoeopathic preparations ........... 1594Barium chloride dihydrate for homoeopathicpreparations .......................................................................... 1594

Barium sulfate ......................................................................... 1797Basic butylated methacrylate copolymer ............................. 1798BCG for immunotherapy......................................................... 894BCG vaccine, freeze-dried....................................................... 895Bearberry leaf .......................................................................... 1264Beclometasone dipropionate ................................................. 1799Beclometasone dipropionate monohydrate......................... 1802Beeswax, white ........................................................................ 1804Beeswax, yellow....................................................................... 1805Belamcanda chinensis rhizome............................................. 1266Belladonna for homoeopathic preparations................. 9.2-4492Belladonna leaf................................................................. 9.2-4452Belladonna leaf dry extract, standardised .................... 9.2-4453Belladonna leaf tincture, standardised.......................... 9.2-4454Belladonna, prepared ...................................................... 9.2-4456Benazepril hydrochloride ...................................................... 1806Bendroflumethiazide.............................................................. 1807Benperidol ............................................................................... 1808Benserazide hydrochloride .................................................... 1810Bentonite.................................................................................. 1811Benzalkonium chloride.......................................................... 1811Benzalkonium chloride solution........................................... 1813Benzathine benzylpenicillin .................................................. 1822Benzbromarone....................................................................... 1815Benzenesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.41).................................................................. 180

Benzethonium chloride ......................................................... 1816Benzocaine............................................................................... 1817Benzoic acid ............................................................................ 1818Benzoin, Siam ......................................................................... 1272Benzoin, Sumatra.................................................................... 1273Benzoin tincture, Siam........................................................... 1274Benzoin tincture, Sumatra..................................................... 1274Benzoyl peroxide, hydrous .................................................... 1819Benzyl alcohol ......................................................................... 1820Benzyl benzoate ...................................................................... 1822Benzylpenicillin, benzathine ................................................. 1822Benzylpenicillin potassium ............................................ 9.2-4505Benzylpenicillin, procaine .............................................. 9.2-4506Benzylpenicillin sodium ................................................. 9.2-4508Betacarotene ............................................................................ 1829Betacyclodextrin .............................................................. 9.3-4857Betacyclodextrin, poly(hydroxypropyl) ether ..................... 2725Betadex.............................................................................. 9.3-4857Betahistine dihydrochloride.................................................. 1831Betahistine mesilate................................................................ 1832Betamethasone ........................................................................ 1833Betamethasone acetate ........................................................... 1835Betamethasone dipropionate.......................................... 9.3-4858Betamethasone sodium phosphate....................................... 1839Betamethasone valerate ......................................................... 1840Betaxolol hydrochloride......................................................... 1842Bezafibrate ............................................................................... 1843Bicalutamide............................................................................ 1845Bifonazole ................................................................................ 1846Bilberry fruit, dried ................................................................ 1275Bilberry fruit dry extract, fresh, refined and standardised.. 1361Bilberry fruit, fresh................................................................. 1276Biological assays (2.7.) ............................................................. 239Biological assays and tests, statistical analysis of results of(5.3.) ................................................................................ 9.2-4353

Biological indicators and related microbial preparations usedin the manufacture of sterile products (5.1.2.) .......... 9.2-4336

Biological products, general texts on (5.2.) ........................... 599Biological products, terminology used in monographs on(5.2.1.) ...................................................................................... 599

5048 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Biological tests (2.6.) ................................................................ 185Biotin........................................................................................ 1847Biperiden hydrochloride........................................................ 1848Biphasic insulin injection ...................................................... 2770Biphasic isophane insulin injection...................................... 2770Birch leaf .................................................................................. 1276Bisacodyl .................................................................................. 1850Bismuth subcarbonate............................................................ 1851Bismuth subgallate.................................................................. 1852Bismuth subnitrate, heavy ..................................................... 1853Bismuth subsalicylate ............................................................. 1854Bisoprolol fumarate ................................................................ 1855Bistort rhizome ....................................................................... 1278Bitter fennel ............................................................................. 1352Bitter-fennel fruit oil .............................................................. 1279Bitter-fennel herb oil .............................................................. 1280Bitterness value (2.8.15.) .......................................................... 288Bitter-orange epicarp and mesocarp .................................... 1283Bitter-orange-epicarp and mesocarp tincture..................... 1284Bitter-orange flower................................................................ 1284Bitter-orange-flower oil.......................................................... 1449Black cohosh............................................................................ 1285Blackcurrant leaf ..................................................................... 1290Black horehound..................................................................... 1289Bleomycin sulfate.................................................................... 1857Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ......................... 432

Blood and blood components, human, materials for containersfor (3.1.1.) ................................................................................ 391

Blood and blood components, sets for the transfusion of(3.2.6.) ...................................................................................... 433

Blood and blood components, sterile plastic containers for(3.2.3.) ...................................................................................... 430

Blood, anticoagulant and preservative solutions for .......... 1738Blood, sterile containers of plasticised poly(vinyl chloride)containing anticoagulant solution (3.2.5.)........................... 432

Bogbean leaf ............................................................................ 1291Boiling point (2.2.12.) ................................................................ 31Boldo leaf ................................................................................. 1292Boldo leaf dry extract............................................................. 1293Borage (starflower) oil, refined ............................................. 1858Borax ........................................................................................ 1859Bordetella bronchiseptica vaccine (live) for dogs............... 1018Boric acid................................................................................. 1859Botulinum antitoxin ............................................................... 1115Botulinum toxin type A for injection .................................. 1860Botulinum toxin type B for injection................................... 1861Bovine insulin .................................................................. 9.3-4929Bovine leptospirosis vaccine (inactivated) .......................... 1019Bovine parainfluenza virus vaccine (live)............................ 1021Bovine respiratory syncytial virus vaccine (live) ................ 1022Bovine rhinotracheitis vaccine (inactivated), infectious ... 1067Bovine rhinotracheitis vaccine (live), infectious ................ 1068Bovine serum .......................................................................... 1863Bovine tuberculin purified protein derivative..................... 3863Bovine viral diarrhoea vaccine (inactivated) ...................... 1023Brimonidine tartrate .............................................................. 1864Bromazepam ........................................................................... 1865Bromhexine hydrochloride............................................. 9.1-4137Bromocriptine mesilate.......................................................... 1868Bromperidol ............................................................................ 1870Bromperidol decanoate.......................................................... 1872Brompheniramine maleate .................................................... 1873Bronchitis vaccine (inactivated), infectious, avian ............. 1007Bronchitis vaccine (live), infectious, avian .......................... 1008Brotizolam ............................................................................... 1875Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) forveterinary use........................................................................ 1024

Buccal tablets and sublingual tablets............................. 9.3-4789Buckwheat herb ...................................................................... 1294Budesonide .............................................................................. 1876Bufexamac ............................................................................... 1878Buffer solutions (4.1.3.)............................................................ 560

Buffer solutions (4.1.3.)................................................... 9.1-4061Buffer solutions (4.1.3.)................................................... 9.2-4324Buffer solutions (4.1.3.)................................................... 9.3-4730Buflomedil hydrochloride...................................................... 1879Bulk density and tapped density of powders (2.9.34.) ......... 359Bumetanide ............................................................................. 1881Bupivacaine hydrochloride.................................................... 1882Buprenorphine ........................................................................ 1884Buprenorphine hydrochloride .............................................. 1886Bursal disease vaccine (inactivated), infectious, avian....... 1010Bursal disease vaccine (live), infectious, avian.................... 1011Buserelin .................................................................................. 1887Buspirone hydrochloride ....................................................... 1889Busulfan ................................................................................... 1891Butcher’s broom...................................................................... 1296Butylated methacrylate copolymer, basic ............................ 1798Butylhydroxyanisole ............................................................... 1893Butylhydroxytoluene .............................................................. 1894Butyl parahydroxybenzoate................................................... 1892

CCabergoline ............................................................................. 1897Cachets.............................................................................. 9.3-4784Cadmium sulfate hydrate for homoeopathic prepara-tions........................................................................................ 1596

Cadmium sulfuricum for homoeopathic preparations...... 1596Caffeine .................................................................................... 1898Caffeine monohydrate............................................................ 1899Calcifediol................................................................................ 1901Calcipotriol.............................................................................. 1902Calcipotriol monohydrate ..................................................... 1904Calcitonin (salmon)................................................................ 1906Calcitriol .................................................................................. 1909Calcium (2.4.3.)......................................................................... 132Calcium acetate....................................................................... 1910Calcium ascorbate .................................................................. 1911Calcium carbonate.................................................................. 1912Calcium carboxymethylcellulose .......................................... 1957Calcium chloride dihydrate................................................... 1912Calcium chloride hexahydrate .............................................. 1913Calcium dobesilate monohydrate ......................................... 1914Calcium edetate, sodium ....................................................... 3568Calcium folinate...................................................................... 1914Calcium glucoheptonate ........................................................ 1917Calcium gluconate .................................................................. 1917Calcium gluconate, anhydrous.............................................. 1918Calcium gluconate for injection ........................................... 1919Calcium glycerophosphate .................................................... 1920Calcium hydrogen phosphate ............................................... 1921Calcium hydrogen phosphate dihydrate.............................. 1922Calcium hydroxide ................................................................. 1923Calcium in adsorbed vaccines (2.5.14.) ................................. 166Calcium iodatum for homoeopathic preparations ............. 1596Calcium iodide tetrahydrate for homoeopathicpreparations .......................................................................... 1596

Calcium lactate........................................................................ 1923Calcium lactate monohydrate ............................................... 1924Calcium lactate pentahydrate................................................ 1924Calcium lactate trihydrate ..................................................... 1925Calcium levofolinate pentahydrate....................................... 1926Calcium levulinate dihydrate ................................................ 1928Calcium pantothenate ............................................................ 1929Calcium pentetate (sodium) for radiopharmaceuticalpreparations ................................................................... 9.3-4800

Calcium phosphate ................................................................. 1929Calcium stearate ..................................................................... 1930Calcium sulfate dihydrate...................................................... 1932Calendula flower..................................................................... 1297Calf coronavirus diarrhoea vaccine (inactivated)............... 1025Calf rotavirus diarrhoea vaccine (inactivated).................... 1026Calicivirosis vaccine (inactivated), feline ............................ 1053Calicivirosis vaccine (live), feline ......................................... 1054

General Notices (1) apply to all monographs and other texts 5049

Index EUROPEAN PHARMACOPOEIA 9.3

Camphor, D-............................................................................ 1932Camphor, racemic .................................................................. 1934Candesartan cilexetil .............................................................. 1935Canine adenovirus vaccine (inactivated)............................. 1027Canine adenovirus vaccine (live).......................................... 1028Canine distemper vaccine (live) ........................................... 1029Canine leptospirosis vaccine (inactivated) .......................... 1030Canine parainfluenza virus vaccine (live) ........................... 1032Canine parvovirosis vaccine (inactivated)........................... 1033Canine parvovirosis vaccine (live)........................................ 1034Cape aloes................................................................................ 1237Capecitabine............................................................................ 1937Cape jasmine fruit .................................................................. 1299Capillary electrophoresis (2.2.47.) ............................................ 81Capillary viscometer method (2.2.9.)....................................... 27Caprylate, sodium................................................................... 3569Caprylic acid ........................................................................... 1938Caprylocaproyl macrogolglycerides .............................. 9.1-4141Capsicum ................................................................................. 1300Capsicum oleoresin, refined and standardised ................... 1302Capsicum soft extract, standardised .................................... 1303Capsicum tincture, standardised .......................................... 1304Capsules ............................................................................ 9.3-4783Capsules and tablets, disintegration of (2.9.1.) ..................... 299Capsules, gastro-resistant ............................................... 9.3-4784Capsules, hard .................................................................. 9.3-4783Capsules, intrauterine .............................................................. 862Capsules, modified-release ............................................. 9.3-4784Capsules, oromucosal...................................................... 9.3-4789Capsules, rectal ......................................................................... 882Capsules, soft.................................................................... 9.3-4783Capsules, vaginal....................................................................... 888Captopril .................................................................................. 1940Caraway fruit........................................................................... 1305Caraway oil .............................................................................. 1306Carbachol................................................................................. 1942Carbamazepine ....................................................................... 1943Carbasalate calcium................................................................ 1945Carbidopa ................................................................................ 1946Carbimazole ............................................................................ 1948Carbocisteine........................................................................... 1949Carbomers ............................................................................... 1950Carbon dioxide ....................................................................... 1951Carbon dioxide in gases (2.5.24.) ........................................... 168Carbon monoxide................................................................... 1953Carbon monoxide (15O) ......................................................... 1130Carbon monoxide in gases (2.5.25.)....................................... 169Carbon monoxide intermix (5 per cent) in nitrogen .. 9.3-4865Carboplatin.............................................................................. 1954Carboprost trometamol ......................................................... 1955Carboxymethylcellulose......................................................... 1957Carboxymethylcellulose calcium .......................................... 1957Carboxymethylcellulose sodium........................................... 1958Carboxymethylcellulose sodium, cross-linked ................... 2174Carboxymethylcellulose sodium, low-substituted.............. 1958Carisoprodol............................................................................ 1956Carmellose............................................................................... 1957Carmellose calcium ................................................................ 1957Carmellose sodium................................................................. 1958Carmellose sodium and microcrystalline cellulose............ 3068Carmellose sodium, low-substituted.................................... 1958Carmustine .............................................................................. 1960Carnauba wax.......................................................................... 1960Carprofen for veterinary use ................................................. 1961Carrageenan ............................................................................ 1962Carrier proteins for the production of conjugatedpolysaccharide vaccines for human use (5.2.11.) ............... 626

Carteolol hydrochloride......................................................... 1963Carvedilol ................................................................................ 1965Cascara..................................................................................... 1307Cascara dry extract, standardised......................................... 1308Cassia oil .................................................................................. 1310Castor oil, hydrogenated........................................................ 1966

Castor oil, polyoxyl................................................................. 2950Castor oil, polyoxyl hydrogenated........................................ 2949Castor oil, refined ................................................................... 1967Castor oil, virgin ..................................................................... 1968Catgut, sterile .......................................................................... 1207Catgut, sterile, in distributor for veterinary use ................. 1219CD34/CD45+ cells in haematopoietic products, numerationof (2.7.23.)................................................................................ 269

Cefaclor.................................................................................... 1969Cefadroxil monohydrate........................................................ 1970Cefalexin monohydrate.......................................................... 1972Cefalotin sodium .................................................................... 1973Cefamandole nafate................................................................ 1974Cefapirin sodium.................................................................... 1976Cefatrizine propylene glycol.................................................. 1977Cefazolin sodium.................................................................... 1978Cefepime dihydrochloride monohydrate ..................... 9.2-4513Cefixime................................................................................... 1983Cefoperazone sodium ............................................................ 1984Cefotaxime sodium ................................................................ 1985Cefoxitin sodium .................................................................... 1987Cefpodoxime proxetil ............................................................ 1989Cefprozil monohydrate .......................................................... 1992Cefradine ................................................................................. 1994Ceftazidime pentahydrate............................................... 9.3-4865Ceftazidime pentahydrate with sodium carbonate forinjection .......................................................................... 9.3-4867

Ceftriaxone sodium................................................................ 2000Cefuroxime axetil ............................................................ 9.2-4515Cefuroxime sodium................................................................ 2003Celandine, greater................................................................... 1380Celecoxib ................................................................................. 2004Celiprolol hydrochloride ....................................................... 2005Cell-based and gene therapy medicinal products, raw materialsof biological origin for the production of (5.2.12.) ............ 627

Cell-based preparations, microbiological examination of(2.6.27.) ........................................................................... 9.2-4297

Cell count and viability, nucleated (2.7.29.).......................... 275Cell cultures for the production of veterinary vaccines(5.2.4.) ...................................................................................... 606

Cell substrates for the production of vaccines for human use(5.2.3.) ............................................................................. 9.3-4733

Cellulose acetate .............................................................. 9.2-4516Cellulose acetate butyrate ...................................................... 2008Cellulose acetate phthalate .................................................... 2009Cellulose, microcrystalline .................................................... 2010Cellulose (microcrystalline) and carmellose sodium......... 3068Cellulose, powdered ............................................................... 2013Centaury .................................................................................. 1310Centella .................................................................................... 1311Cetirizine dihydrochloride .................................................... 2017Cetostearyl alcohol ................................................................. 2019Cetostearyl alcohol (type A), emulsifying ........................... 2019Cetostearyl alcohol (type B), emulsifying ........................... 2021Cetostearyl isononanoate ...................................................... 2022Cetostearyl sulfate, sodium ................................................... 3571Cetrimide................................................................................. 2022Cetyl alcohol............................................................................ 2023Cetyl palmitate ........................................................................ 2024Cetylpyridinium chloride ...................................................... 2025Ceylon cinnamon bark oil ..................................................... 1318Ceylon cinnamon leaf oil....................................................... 1318CFC assay for human haematopoietic progenitor cells(2.7.28.) .................................................................................... 274

Chamomile flower, Roman ................................................... 1313Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) ................... 354

Characterisation of crystalline solids by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 109

Characterisation of preparations for nebulisation (2.9.44.).. 378Characters section in monographs (5.11.) ............................ 729Charcoal, activated ................................................................. 2025Chemical imaging (5.24.) ............................................... 9.3-4767

5050 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Chemical precursors for radiopharmaceuticalpreparations ............................................................................ 813

Chemometric methods applied to analytical data (5.21.) ... 783Chenodeoxycholic acid ......................................................... 2026Chewable tablets .............................................................. 9.3-4792Chewing gums, medicated ............................................. 9.3-4784Chewing gums, medicated, dissolution test for (2.9.25.)..... 340Chicken anaemia vaccine (live), infectious ......................... 1069Chicken flocks free from specified pathogens for theproduction and quality control of vaccines (5.2.2.) ........... 599

Chinese goldthread rhizome .......................................... 9.1-4102Chitosan hydrochloride ......................................................... 2028Chlamydiosis vaccine (inactivated), feline ......................... 1055Chloral hydrate ....................................................................... 2029Chlorambucil .......................................................................... 2029Chloramine.............................................................................. 3816Chloramphenicol ............................................................. 9.1-4142Chloramphenicol palmitate................................................... 2032Chloramphenicol sodium succinate..................................... 2033Chlorcyclizine hydrochloride................................................ 2034Chlordiazepoxide.................................................................... 2035Chlordiazepoxide hydrochloride .......................................... 2036Chlorhexidine diacetate .................................................. 9.3-4869Chlorhexidine digluconate solution .............................. 9.3-4871Chlorhexidine dihydrochloride ..................................... 9.3-4874Chlorides (2.4.4.) ...................................................................... 132Chlormadinone acetate.......................................................... 2043Chlorobutanol ......................................................................... 2045Chlorobutanol hemihydrate .................................................. 2046Chlorocresol ............................................................................ 2046Chloroquine phosphate ......................................................... 2047Chloroquine sulfate ................................................................ 2048Chlorphenamine maleate ...................................................... 2048Chlorpromazine hydrochloride ............................................ 2050Chlorpropamide ..................................................................... 2051Chlorprothixene hydrochloride............................................ 2052Chlortalidone .......................................................................... 2054Chlortetracycline hydrochloride........................................... 2055Cholecalciferol ........................................................................ 2058Cholecalciferol concentrate (oily form)............................... 2059Cholecalciferol concentrate (powder form) ........................ 2061Cholecalciferol concentrate (water-dispersible form)........ 2062Cholera vaccine (inactivated), fowl ...................................... 1063Cholera vaccine (inactivated, oral)......................................... 898Cholesterol............................................................................... 2064Cholesterol for parenteral use ........................................ 9.2-4517Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ..... 157Chondroitin sulfate sodium .................................................. 2067Chromatographic separation techniques (2.2.46.) ...... 9.2-4286Chromatography, gas (2.2.28.).................................................. 44Chromatography, liquid (2.2.29.) ............................................. 46Chromatography, paper (2.2.26.) ............................................. 42Chromatography, size-exclusion (2.2.30.) ............................... 47Chromatography, supercritical fluid (2.2.45.)......................... 74Chromatography, thin-layer (2.2.27.) ...................................... 43Chromium (51Cr) edetate injection ...................................... 1131Chymotrypsin ......................................................................... 2069Ciclesonide .............................................................................. 2070Ciclopirox ................................................................................ 2071Ciclopirox olamine ................................................................. 2072Ciclosporin .............................................................................. 2074Cilastatin sodium.................................................................... 2075Cilazapril.................................................................................. 2077Cimetidine ............................................................................... 2078Cimetidine hydrochloride ..................................................... 2080Cinchocaine hydrochloride ................................................... 2082Cinchona bark......................................................................... 1314Cinchona liquid extract, standardised ................................. 1316Cineole ..................................................................................... 2083Cineole in essential oils, 1,8-, assay of (2.8.11.) .................... 285Cineole type niaouli oil.......................................................... 1453Cinnamon................................................................................ 1317Cinnamon bark oil, Ceylon................................................... 1318

Cinnamon leaf oil, Ceylon..................................................... 1318Cinnarizine.............................................................................. 2084Ciprofibrate ............................................................................. 2085Ciprofloxacin........................................................................... 2086Ciprofloxacin hydrochloride ................................................. 2088Circular dichroism (2.2.41.) ...................................................... 69Cisatracurium besilate ........................................................... 2089Cisplatin................................................................................... 2094Citalopram hydrobromide.............................................. 9.3-4876Citalopram hydrochloride .............................................. 9.3-4877Citric acid ................................................................................ 2098Citric acid monohydrate ........................................................ 2099Citronella oil............................................................................ 1319Cladribine ................................................................................ 2100Clarithromycin........................................................................ 2101Clarity and degree of opalescence of liquids (2.2.1.)... 9.2-4285Clary sage oil ........................................................................... 1320Classical swine-fever vaccine (live, prepared in cellcultures) ................................................................................. 1104

Clazuril for veterinary use..................................................... 2104Clebopride malate .................................................................. 2106Clemastine fumarate ....................................................... 9.3-4879Clematis armandii stem.................................................. 9.3-4813Clenbuterol hydrochloride .................................................... 2109Clindamycin hydrochloride ........................................... 9.3-4880Clindamycin phosphate ......................................................... 2111Clioquinol................................................................................ 2114Clobazam................................................................................. 2115Clobetasol propionate ............................................................ 2116Clobetasone butyrate.............................................................. 2118Clodronate disodium tetrahydrate ....................................... 2119Clofazimine ............................................................................. 2120Clofibrate ................................................................................. 2122Clomifene citrate .................................................................... 2122Clomipramine hydrochloride ............................................... 2124Clonazepam............................................................................. 2126Clonidine hydrochloride........................................................ 2127Clopamide ............................................................................... 2128Clopidogrel besilate ................................................................ 2129Clopidogrel hydrochloride .................................................... 2131Clopidogrel hydrogen sulfate ................................................ 2133Clorazepate, dipotassium....................................................... 2291Closantel sodium dihydrate for veterinary use................... 2134Clostridium botulinum vaccine for veterinary use ............ 1035Clostridium chauvoei vaccine for veterinary use ............... 1036Clostridium novyi (type B) vaccine for veterinary use...... 1036Clostridium perfringens vaccine for veterinary use........... 1038Clostridium septicum vaccine for veterinary use............... 1040Closures and containers for parenteral preparationsand ophthalmic preparations, polypropylene for(3.1.6.) ............................................................................. 9.2-4314

Closures and containers for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 428

Closures and tubing, silicone elastomer for (3.1.9.) ............. 409Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) ...................................................................................... 435

Clotrimazole............................................................................ 2136Clove......................................................................................... 1322Clove oil ................................................................................... 1323Cloxacillin sodium ................................................................. 2137Clozapine ................................................................................. 2139Coagulation factor II, human, assay of (2.7.18.)................... 266Coagulation factor IX, human .............................................. 2674Coagulation factor IX, human, assay of (2.7.11.) ................. 259Coagulation factor IX (rDNA) concentrated solution,human ............................................................................. 9.3-4915

Coagulation factor IX (rDNA) powder for solution forinjection, human............................................................ 9.3-4920

Coagulation factors, activated (2.6.22.) ................................. 219Coagulation factors, assay of heparin (2.7.12.) ..................... 259Coagulation factor VIIa (rDNA) concentrated solution,human .................................................................................... 2668

General Notices (1) apply to all monographs and other texts 5051

Index EUROPEAN PHARMACOPOEIA 9.3

Coagulation factor VII, human ............................................ 2666Coagulation factor VII, human, assay of (2.7.10.)................ 258Coagulation factor VIII, human........................................... 2672Coagulation factor VIII, human, assay of (2.7.4.) ................ 246Coagulation factor VIII (rDNA), human ............................ 2673Coagulation factor X, assay of (2.7.19.) ................................. 266Coagulation factor XI, human .............................................. 2681Coagulation factor XI, human, assay of (2.7.22.) ................. 269Coated granules ........................................................................ 860Coated tablets................................................................... 9.3-4791Cocaine hydrochloride........................................................... 2140Coccidiosis vaccine (live) for chickens ................................ 1042Cocculus for homoeopathic preparations ........................... 1597Coconut oil, refined................................................................ 2141Cocoyl caprylocaprate............................................................ 2142Codeine.................................................................................... 2143Codeine hydrochloride dihydrate......................................... 2144Codeine phosphate hemihydrate .......................................... 2146Codeine phosphate sesquihydrate ........................................ 2148Codergocrine mesilate ........................................................... 2149Cod-liver oil, farmed.............................................................. 2151Cod-liver oil (type A)............................................................. 2155Cod-liver oil (type B) ............................................................. 2159Codonopsis root ..............................................................9.3-4815Coix seed........................................................................... 9.2-4457Cola .......................................................................................... 1326Colchicine................................................................................ 2162Cold-water vibriosis vaccine (inactivated) forsalmonids........................................................................ 9.2-4428

Colestyramine ......................................................................... 2164Colibacillosis vaccine (inactivated), neonatal piglet .......... 1077Colibacillosis vaccine (inactivated), neonatal ruminant.... 1079Colistimethate sodium.................................................... 9.2-4519Colistin sulfate ........................................................................ 2166Colloidal anhydrous silica ..................................................... 3549Colloidal hydrated silica ........................................................ 3550Colloidal silica, hydrophobic ................................................ 3551Colloidal silver, for external use ........................................... 3552Colony-forming cell assay for human haematopoieticprogenitor cells (2.7.28.) ........................................................ 274

Colophony ............................................................................... 1327Coloration of liquids (2.2.2.) ..................................................... 22Common selfheal fruit-spike ................................................ 1327Common stinging nettle for homoeopathic preparations.. 1614Comparative table of porosity of sintered-glass filters(2.1.2.) ........................................................................................ 15

Complexometric titrations (2.5.11.) ....................................... 164Composition of fatty acids by gas chromatography(2.4.22.) .................................................................................... 141

Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) .................................................................................... 155

Compressed lozenges ...................................................... 9.3-4789Concentrated solutions for haemodialysis .......................... 2628Concentrates for injections or infusions................................ 872Concentrates for intrauterine solutions ................................. 862Conductivity (2.2.38.) ................................................................ 62Coneflower herb, purple ........................................................ 1486Coneflower root, narrow-leaved ........................................... 1447Coneflower root, pale............................................................. 1467Coneflower root, purple......................................................... 1488Conjugated estrogens ............................................................. 2410Conjugated polysaccharide vaccines for human use, carrierproteins for the production of (5.2.11.) ............................... 626

Consistency by penetrometry, measurement of (2.9.9.) ...... 313Containers (3.2.) ....................................................................... 423Containers and closures for parenteral preparationsand ophthalmic preparations, polypropylene for(3.1.6.) ............................................................................. 9.2-4314

Containers and closures for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 428

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for(3.1.7.) ............................................................................. 9.2-4318

Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ................................................................................... 429

Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) .................................................................................... 416

Containers for human blood and blood components, materialsbased on plasticised poly(vinyl chloride) for (3.1.1.1.)...... 391

Containers for human blood and blood components, materialsfor (3.1.1.) ................................................................................ 391

Containers for human blood and blood components, plastic,sterile (3.2.3.)........................................................................... 430

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) .................................................................................... 410

Containers for parenteral preparations and forophthalmic preparations, polyethylene with additives for(3.1.5.) ............................................................................. 9.2-4311

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for(3.1.4.) ............................................................................. 9.2-4310

Containers for pharmaceutical use, glass (3.2.1.) ................. 423Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) ................................ 419

Containers for solid dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.) .................................................................................... 412

Containers, materials used for the manufacture of (3.1.).... 391Containers of plasticised poly(vinyl chloride) for human bloodand blood components, empty sterile (3.2.4.)..................... 432

Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.2.5.) .............. 432

Contamination, microbial : microbial enumeration tests(2.6.12.) .................................................................................... 195

Contamination, microbial : test for specified micro-organisms(2.6.13.) .................................................................................... 199

Content uniformity of single-dose preparations (2.9.6.) ..... 312Control of impurities in substances for pharmaceutical use(5.10.) ....................................................................................... 723

Control of microbiological quality, alternative methods for(5.1.6.) ............................................................................. 9.2-4339

Copolymer, basic butylated methacrylate ........................... 1798Copolymer, grafted, macrogol poly(vinyl alcohol) ............ 2945Copolymer, methacrylic acid - ethyl acrylate (1:1) ............ 3015Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion30 per cent ............................................................................. 3017

Copolymer, methacrylic acid – methyl methacrylate(1:1) ........................................................................................ 3018

Copolymer, methacrylic acid - methyl methacrylate(1:2) ........................................................................................ 3019

Copolymer (type A), ammonio methacrylate..................... 1712Copolymer (type B), ammonio methacrylate ..................... 1713Copovidone ...................................................................... 9.3-4882Copper acetate monohydrate for homoeopathicpreparations .......................................................................... 1599

Copper for homoeopathic preparations .............................. 1600Copper sulfate ......................................................................... 2169Copper sulfate pentahydrate ................................................. 2170Copper tetramibi tetrafluoroborate for radiopharmaceuticalpreparations ................................................................... 9.2-4435

Coriander................................................................................. 1329Coriander oil ........................................................................... 1330Coronavirus diarrhoea vaccine (inactivated), calf ............. 1025Cortisone acetate .................................................................... 2170Cotton, absorbent ................................................................... 2172Cottonseed oil, hydrogenated .............................................. 2173Couch grass rhizome.............................................................. 1331Creams ....................................................................................... 883Cresol, crude ........................................................................... 2173Crocus for homoeopathic preparations ............................... 1599Cromoglicate, sodium............................................................ 3574Croscarmellose sodium ......................................................... 2174Crospovidone .......................................................................... 2175Crotamiton .............................................................................. 2177

5052 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.)............... 354

Crystalline solids, characterisation by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 109

Crystallinity (5.16.)................................................................... 757Cuprum aceticum for homoeopathic preparations............ 1599Cuprum metallicum for homoeopathic preparations........ 1600Cutaneous application, liquid preparations for .................... 864Cutaneous application, powders for....................................... 874Cutaneous application, semi-solid preparations for ............ 882Cutaneous application, veterinary liquid preparationsfor .................................................................................... 9.3-4792

Cutaneous foams ...................................................................... 864Cutaneous patches .................................................................... 882Cyanocobalamin ..................................................................... 2178Cyanocobalamin (57Co) capsules .......................................... 1132Cyanocobalamin (57Co) solution .......................................... 1133Cyanocobalamin (58Co) capsules .......................................... 1134Cyanocobalamin (58Co) solution .......................................... 1134Cyclamate, sodium ................................................................. 3576Cyclizine hydrochloride......................................................... 2179Cyclopentolate hydrochloride ............................................... 2180Cyclophosphamide ................................................................. 2181Cyproheptadine hydrochloride............................................. 2182Cyproterone acetate................................................................ 2183Cysteine hydrochloride monohydrate.................................. 2185Cystine ..................................................................................... 2187Cytarabine ............................................................................... 2188

DDacarbazine............................................................................. 2193Dalteparin sodium.................................................................. 2194Danaparoid sodium................................................................ 2196Dandelion herb with root ...................................................... 1332Dandelion root........................................................................ 1333Dapsone ................................................................................... 2198Daunorubicin hydrochloride ................................................ 2199D-Camphor.............................................................................. 1932Decyl oleate ............................................................................. 2200Deferoxamine mesilate.................................................... 9.3-4887Degree of coloration of liquids (2.2.2.) .................................... 22Dembrexine hydrochloride monohydrate for veterinaryuse.................................................................................... 9.2-4526

Demeclocycline hydrochloride ............................................. 2203Demonstration of uniformity of dosage units using largesample sizes (2.9.47.).............................................................. 384

Density of powders, bulk density and tapped (2.9.34.)........ 359Density of solids (2.2.42.) .......................................................... 70Density of solids, gas pycnometric (2.9.23.).......................... 339Density, relative (2.2.5.) ............................................................. 25Dental type silica .................................................................... 3550Depressor substances (2.6.11.) ................................................ 195Deptropine citrate................................................................... 2205Dequalinium chloride ............................................................ 2206Desacyl-4-monophosphoryl lipid A, 3-O- ......................... 2207Desflurane................................................................................ 2209Desipramine hydrochloride................................................... 2210Deslanoside ............................................................................. 2211Desloratadine .......................................................................... 2212Desmopressin .......................................................................... 2213Desogestrel .............................................................................. 2215Desoxycortone acetate ........................................................... 2216Detection and measurement of radioactivity (2.2.66.) ........ 113Detector tubes, gas (2.1.6.) ............................................. 9.3-4685Determination of aflatoxin B1 in herbal drugs (2.8.18.) ...... 289Determination of bactericidal, fungicidal or yeasticidal activityof antiseptic medicinal products (5.1.11.) .................. 9.2-4348

Determination of elemental impurities (2.4.20) .......... 9.3-4701Determination of metal catalyst or metal reagent residues(2.4.20.) ........................................................................... 9.3-4701

Determination of nitrogen by sulfuric acid digestion(2.5.9.) ...................................................................................... 164

Determination of primary aromatic amino-nitrogen(2.5.8.) ...................................................................................... 163

Determination of water by distillation (2.2.13.) ..................... 31Detomidine hydrochloride for veterinary use .................... 2217Devil’s claw dry extract .......................................................... 1334Devil’s claw root ...................................................................... 1335Dexamethasone....................................................................... 2218Dexamethasone acetate.......................................................... 2220Dexamethasone isonicotinate ............................................... 2222Dexamethasone sodium phosphate...................................... 2223Dexchlorpheniramine maleate.............................................. 2226Dexpanthenol.......................................................................... 2227Dextran 1 for injection........................................................... 2228Dextran 40 for injection ........................................................ 2229Dextran 60 for injection ........................................................ 2230Dextran 70 for injection ........................................................ 2231Dextranomer ........................................................................... 2231Dextrans, molecular mass distribution in (2.2.39.)................ 62Dextrin .............................................................................. 9.2-4527Dextromethorphan hydrobromide....................................... 2233Dextromoramide tartrate ...................................................... 2234Dextropropoxyphene hydrochloride.................................... 2235Dextrose............................................................................ 9.1-4167Dextrose monohydrate.................................................... 9.1-4168Diacerein.................................................................................. 2236Diazepam................................................................................. 2238Diazoxide ................................................................................. 2240Dibrompropamidine diisetionate ......................................... 2240Dibutyl phthalate .................................................................... 2241Dichlorobenzyl alcohol, 2,4- ................................................. 2242Dichloromethane .................................................................... 3034Diclazuril for veterinary use.................................................. 2243Diclofenac potassium ............................................................. 2245Diclofenac sodium.................................................................. 2246Dicloxacillin sodium .............................................................. 2248Dicycloverine hydrochloride.......................................... 9.1-4147Didanosine .............................................................................. 2250Dienogest ................................................................................. 2252Diethylcarbamazine citrate.................................................... 2254Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)................................................................. 157

Diethylene glycol monoethyl ether ...................................... 2256Diethylene glycol palmitostearate......................................... 2257Diethyl phthalate .................................................................... 2253Diethylstilbestrol..................................................................... 2258Diffraction, laser light, particle size analysis by (2.9.31.) ... 349Difloxacin hydrochloride trihydrate for veterinary use..... 2259Digitalis leaf............................................................................. 1336Digitoxin .................................................................................. 2260Digoxin .................................................................................... 2261Dihydralazine sulfate, hydrated ..................................... 9.2-4528Dihydrocodeine hydrogen tartrate ....................................... 2266Dihydroergocristine mesilate ................................................ 2267Dihydroergotamine mesilate................................................. 2269Dihydroergotamine tartrate .................................................. 2271Dihydrostreptomycin sulfate for veterinary use ................. 2272Dihydrotachysterol ................................................................. 2274Diltiazem hydrochloride........................................................ 2276Dimenhydrinate...................................................................... 2277Dimercaprol ............................................................................ 2279Dimethylacetamide ................................................................ 2280Dimethylaniline, N,N- (2.4.26.) .............................................. 152Dimethyl sulfoxide ................................................................. 2279Dimeticone .............................................................................. 2281Dimetindene maleate ............................................................. 2282Dinoprostone ................................................................... 9.2-4529Dinoprost trometamol ........................................................... 2283Dioscorea nipponica rhizome ........................................ 9.2-4458Dioscorea oppositifolia rhizome........................................... 1337Diosmin ................................................................................... 2286Dioxan and ethylene oxide (2.4.25.)....................................... 151Dip concentrates .............................................................. 9.3-4792Diphenhydramine hydrochloride ......................................... 2288

General Notices (1) apply to all monographs and other texts 5053

Index EUROPEAN PHARMACOPOEIA 9.3

Diphenoxylate hydrochloride................................................ 2289Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 273

Diphtheria and tetanus vaccine (adsorbed) .......................... 899Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content).................................................................................... 900

Diphtheria antitoxin............................................................... 1115Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 901

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed) ................................................................. 902

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed, reduced antigen(s) content)................. 903

Diphtheria, tetanus and pertussis (whole cell) vaccine(adsorbed) ............................................................................... 905

Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)............................... 906

Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ............ 908

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 910

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)................... 911

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 913

Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ............ 915

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 917

Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 920

Diphtheria, tetanus, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 922

Diphtheria vaccine (adsorbed)................................................ 924Diphtheria vaccine (adsorbed), assay of (2.7.6.)................... 247Diphtheria vaccine (adsorbed, reduced antigen content) ... 925Dipivefrine hydrochloride ..................................................... 2290Dipotassium clorazepate........................................................ 2291Dipotassium phosphate ......................................................... 2292Diprophylline .......................................................................... 2293Dipyridamole .......................................................................... 2294Dirithromycin ......................................................................... 2296Disintegration of suppositories and pessaries (2.9.2.) ......... 301Disintegration of tablets and capsules (2.9.1.) ...................... 299Disodium clodronate tetrahydrate ....................................... 2119Disodium edetate.................................................................... 2297Disodium etidronate .............................................................. 2433Disodium pamidronate pentahydrate .................................. 3259Disodium phosphate .............................................................. 2298Disodium phosphate dihydrate............................................. 2299Disodium phosphate dodecahydrate.................................... 2299Disopyramide.......................................................................... 2300Disopyramide phosphate ....................................................... 2301Dispersible tablets............................................................ 9.3-4792Dissolution, apparent (2.9.43.)................................................ 377Dissolution, intrinsic (2.9.29.) ................................................ 347Dissolution test for lipophilic solid dosage forms (2.9.42.).. 377Dissolution test for solid dosage forms (2.9.3.) .................... 302Dissolution test for transdermal patches (2.9.4.).................. 309Dissolution testing, recommendations on (5.17.1.) ............. 761Distemper vaccine (live), canine........................................... 1029Distemper vaccine (live) for mustelids ................................ 1045Distillation range (2.2.11.)......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) .................................................................................... 367

Disulfiram................................................................................ 2302Dithranol ................................................................................. 2303DL-Methionine ........................................................................ 3025DL-α-Tocopheryl hydrogen succinate................................... 3806

Dobesilate monohydrate, calcium ........................................ 1914Dobutamine hydrochloride ................................................... 2304Docetaxel ................................................................................. 2305Docetaxel trihydrate ............................................................... 2307Docusate sodium .................................................................... 2309Dodecyl gallate........................................................................ 2309Dog rose................................................................................... 1338Domperidone .......................................................................... 2310Domperidone maleate............................................................ 2312Dopamine hydrochloride ...................................................... 2313Dopexamine dihydrochloride ............................................... 2315Dorzolamide hydrochloride .................................................. 2316Dosage forms (glossary) ................................................. 9.2-4423Dosage units, demonstration of uniformity using large samplesizes (2.9.47.) ........................................................................... 384

Dosage units, uniformity of (2.9.40.) ............................ 9.1-4055Dosulepin hydrochloride....................................................... 2318DOTATOC (gallium (68Ga)) injection ................................. 1150Doxapram hydrochloride ...................................................... 2319Doxazosin mesilate................................................................. 2320Doxepin hydrochloride .......................................................... 2322Doxorubicin hydrochloride................................................... 2323Doxycycline hyclate ................................................................ 2324Doxycycline monohydrate..................................................... 2326Doxylamine hydrogen succinate........................................... 2328Droperidol ............................................................................... 2329Droppers (2.1.1.)......................................................................... 15Drop point (2.2.17.).................................................................... 33Drops (nasal) and sprays (liquid nasal) ................................. 867Drops, oral ........................................................................ 9.3-4786Drospirenone .......................................................................... 2331Dry extracts ............................................................................... 818Drynaria rhizome ............................................................ 9.2-4459Dry residue of extracts (2.8.16.).............................................. 289Duck plague vaccine (live)..................................................... 1046Duck viral hepatitis type I vaccine (live) ............................. 1047Duloxetine hydrochloride...................................................... 2332Dutasteride .............................................................................. 2334Dwarf pine oil ......................................................................... 1340Dydrogesterone....................................................................... 2336

EEar drops and ear sprays.......................................................... 856Ear powders............................................................................... 856Ear preparations........................................................................ 855Ear preparations, semi-solid ................................................... 856Ear sprays and ear drops.......................................................... 856Ear tampons .............................................................................. 856Ear washes ................................................................................. 856Ebastine.................................................................................... 2341Eclipta herb ...................................................................... 9.2-4461Econazole................................................................................. 2342Econazole nitrate .................................................................... 2343Edetate (chromium (51Cr)) injection.................................... 1131Edetate, disodium................................................................... 2297Edetate, sodium calcium........................................................ 3568Edetic acid ............................................................................... 2344Edotreotide (gallium (68Ga)) injection................................. 1150Edrophonium chloride........................................................... 2345Effervescent granules ............................................................... 860Effervescent powders ............................................................... 875Effervescent tablets.......................................................... 9.3-4791Efficacy of antimicrobial preservation (5.1.3.)...................... 577Efficacy of veterinary vaccines and immunosera, evaluation of(5.2.7.) ...................................................................................... 612

Egg drop syndrome 76 vaccine (inactivated) ..................... 1048Egg phospholipids for injection..................................... 9.2-4533Elder flower ............................................................................. 1342Electrophoresis (2.2.31.) ............................................................ 48Electrophoresis, capillary (2.2.47.) ........................................... 81Elemental impurities (5.20.)........................................... 9.3-4759Elemental impurities, determination of (2.4.20) ......... 9.3-4701

5054 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Eleutherococcus...................................................................... 1344Emedastine difumarate .......................................................... 2346Emetine hydrochloride pentahydrate .................................. 2347Empty sterile containers of plasticised poly(vinyl chloride) forhuman blood and blood components (3.2.4.)..................... 432

Emulsifying cetostearyl alcohol (type A)............................. 2019Emulsifying cetostearyl alcohol (type B) ............................. 2021Emulsions, solutions and suspensions, oral ................. 9.3-4786Enalaprilat dihydrate.............................................................. 2349Enalapril maleate .................................................................... 2348Encephalitis vaccine (inactivated), tick-borne...................... 988Encephalomyelitis vaccine (live), infectious, avian ............ 1013Endotoxins, bacterial (2.6.14.) ....................................... 9.3-4707Endotoxins, bacterial, guidelines for using the test for(5.1.10.) .................................................................................... 593

Enilconazole for veterinary use ............................................ 2351Enoxaparin sodium ................................................................ 2352Enoxolone ................................................................................ 2354Enrofloxacin for veterinary use...................................... 9.2-4535Entacapone .............................................................................. 2357Entecavir monohydrate.......................................................... 2359Enzootic pneumonia vaccine (inactivated), porcine.......... 1086Ephedra herb ........................................................................... 1346Ephedrine ................................................................................ 2360Ephedrine hemihydrate ......................................................... 2361Ephedrine hydrochloride....................................................... 2362Ephedrine hydrochloride, racemic ....................................... 2363Epinastine hydrochloride....................................................... 2364Epinephrine ............................................................................. 1650Epinephrine tartrate ............................................................... 1652Epirubicin hydrochloride ...................................................... 2365Eplerenone............................................................................... 2367Eptacog alfa (activated) concentrated solution................... 2668Equine herpesvirus vaccine (inactivated)............................ 1050Equine influenza vaccine (inactivated) ................................ 1051Equisetum stem ...................................................................... 1347Ergocalciferol .......................................................................... 2368Ergoloid mesilates................................................................... 2149Ergometrine maleate .............................................................. 2370Ergotamine tartrate ................................................................ 2371Erysipelas vaccine (inactivated), swine................................ 1104Erythritol ................................................................................. 2373Erythromycin .......................................................................... 2374Erythromycin estolate ............................................................ 2378Erythromycin ethylsuccinate.......................................... 9.3-4893Erythromycin lactobionate ............................................. 9.2-4536Erythromycin stearate ............................................................ 2388Erythropoietin concentrated solution.................................. 2391Escitalopram............................................................................ 2395Escitalopram oxalate .............................................................. 2397Eserine salicylate..................................................................... 3335Esketamine hydrochloride.............................................. 9.3-4895Esomeprazole magnesium dihydrate ................................... 2401Esomeprazole magnesium trihydrate................................... 2402Essential oils .............................................................................. 814Essential oils, assay of 1,8-cineole in (2.8.11.)....................... 285Essential oils, fatty oils and resinified essential oils in(2.8.7.) ...................................................................................... 284

Essential oils, foreign esters in (2.8.6.) ................................... 284Essential oils in herbal drugs (2.8.12.) ................................... 285Essential oils, odour and taste (2.8.8.) ................................... 284Essential oils, residue on evaporation (2.8.9.)....................... 284Essential oils, solubility in alcohol (2.8.10.) .......................... 284Essential oils, water in (2.8.5.)................................................. 284Ester value (2.5.2.) .................................................................... 161Estradiol benzoate .................................................................. 2404Estradiol hemihydrate..................................................... 9.1-4151Estradiol valerate .................................................................... 2407Estriol ....................................................................................... 2409Estrogens, conjugated............................................................. 2410Etacrynic acid.......................................................................... 2413Etamsylate................................................................................ 2414Ethacridine lactate monohydrate.......................................... 2415

Ethambutol hydrochloride .................................................... 2416Ethanol (96 per cent).............................................................. 2417Ethanol, anhydrous................................................................. 2419Ethanol content (2.9.10.) ......................................................... 315Ether ......................................................................................... 2421Ether, anaesthetic.................................................................... 2422Ethinylestradiol ....................................................................... 2422Ethionamide ............................................................................ 2424Ethosuximide .......................................................................... 2425Ethoxylated substances, ethylene glycol and diethylene glycolin (2.4.30.) ............................................................................... 157

Ethyl acetate ............................................................................ 2427Ethyl acrylate - methacrylic acid copolymer (1:1).............. 3015Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion30 per cent ............................................................................. 3017

Ethylcellulose.................................................................... 9.2-4539Ethylenediamine ..................................................................... 2431Ethylene glycol and diethylene glycol in ethoxylated substances(2.4.30.) .................................................................................... 157

Ethylene glycol monopalmitostearate .................................. 2430Ethylene glycol monostearate................................................ 2430Ethylene oxide and dioxan (2.4.25.) ....................................... 151Ethylhexanoic acid, 2- (2.4.28.)............................................... 154Ethylmorphine hydrochloride............................................... 2431Ethyl oleate .............................................................................. 2428Ethyl parahydroxybenzoate ................................................... 2428Ethyl parahydroxybenzoate sodium..................................... 3577Etidronate disodium............................................................... 2433Etilefrine hydrochloride......................................................... 2433Etodolac ................................................................................... 2435Etofenamate............................................................................. 2437Etomidate................................................................................. 2439Etoposide ..........................................................................9.1-4152Eucalyptus leaf ........................................................................ 1349Eucalyptus oil .......................................................................... 1349Eucommia bark................................................................ 9.2-4462Eugenol .................................................................................... 2443European goldenrod............................................................... 1376European viper venom antiserum ........................................ 1119Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.) ...................................................................................... 612

Evaluation of safety of each batch of immunosera forveterinary use (5.2.9.)............................................................. 625

Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ...................................................................................... 610

Evening primrose oil, refined................................................ 2444Evodia fruit.......................................................................9.2-4464Excipients, functionality-related characteristics of(5.15.) .............................................................................. 9.2-4411

Exemestane.............................................................................. 2445Extemporaneous preparation of radiopharmaceuticals(5.19.) ....................................................................................... 767

Extractable volume of parenteral preparations, test for(2.9.17.) .................................................................................... 322

Extracts, dry .............................................................................. 818Extracts, dry residue of (2.8.16.)............................................. 289Extracts, herbal drug ................................................................ 815Extracts, herbal drug, monographs on (information chapter)(5.23.) ....................................................................................... 807

Extracts, liquid (fluid) .............................................................. 817Extracts, loss on drying of (2.8.17.)........................................ 289Extracts, soft .............................................................................. 817Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological examination (2.6.31.) ........... 232

Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological quality (5.1.8.) ....................... 591

Extracts, water for preparation of......................................... 3932Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ........................................................................... 9.3-4711

Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.) ......................................... 222

Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) .................................................................................... 219

General Notices (1) apply to all monographs and other texts 5055

Index EUROPEAN PHARMACOPOEIA 9.3

Eye drops ................................................................................... 857Eye lotions ................................................................................. 857Eye preparations ....................................................................... 857Eye preparations, semi-solid ................................................... 858

FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) ............................................................. 580

Factor II, human coagulation, assay of (2.7.18.)................... 266Factor IX, human coagulation .............................................. 2674Factor IX, human coagulation, assay of (2.7.11.) ................. 259Factor IX (rDNA) concentrated solution, humancoagulation .....................................................................9.3-4915

Factor IX (rDNA) powder for solution for injection, humancoagulation ..................................................................... 9.3-4920

Factor VIIa (rDNA) concentrated solution, human coagulation................................................................................................ 2668

Factor VII, human coagulation............................................. 2666Factor VII, human coagulation, assay of (2.7.10.)................ 258Factor VIII, human coagulation ........................................... 2672Factor VIII, human coagulation, assay of (2.7.4.) ................ 246Factor VIII (rDNA), human coagulation ............................ 2673Factor X, human coagulation, assay of (2.7.19.) ................... 266Factor XI, human coagulation .............................................. 2681Factor XI, human coagulation, assay of (2.7.22.) ................. 269Falling ball and automatic rolling ball viscometer methods(2.2.49.) ........................................................................... 9.3-4690

Famotidine............................................................................... 2449Fat, hard ................................................................................... 2639Fat, hard with additives.......................................................... 2640Fatty acids, composition by gas chromatography (2.4.22.).. 141Fatty acids in oils rich in omega-3 acids, composition of(2.4.29.) .................................................................................... 155

Fatty oils, alkaline impurities in (2.4.19.) .............................. 138Fatty oils and resinified essential oils in essential oils(2.8.7.) ...................................................................................... 284

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) .................................................................................... 141

Fatty oils, identification by thin-layer chromatography(2.3.2.) ...................................................................................... 126

Fatty oils, sterols in (2.4.23.).................................................... 144Fatty oils, vegetable................................................................... 848Fc function of immunoglobulin, test for (2.7.9.) ......... 9.3-4724Febantel for veterinary use .................................................... 2450Feeding stuffs for veterinary use, medicated, premixes for.. 875Felbinac .................................................................................... 2451Feline calicivirosis vaccine (inactivated).............................. 1053Feline calicivirosis vaccine (live)........................................... 1054Feline chlamydiosis vaccine (inactivated) ........................... 1055Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .......................................................................... 1056

Feline infectious enteritis (feline panleucopenia) vaccine(live) ....................................................................................... 1057

Feline leukaemia vaccine (inactivated) ................................ 1058Feline panleucopenia vaccine (inactivated)......................... 1056Feline panleucopenia vaccine (live) ..................................... 1057Feline viral rhinotracheitis vaccine (inactivated) ............... 1059Feline viral rhinotracheitis vaccine (live) ............................ 1060Felodipine ................................................................................ 2452Felypressin ............................................................................... 2454Fenbendazole for veterinary use........................................... 2455Fenbufen .................................................................................. 2456Fennel, bitter ........................................................................... 1352Fennel, sweet ........................................................................... 1353Fenofibrate............................................................................... 2457Fenoterol hydrobromide ........................................................ 2458Fentanyl.................................................................................... 2459Fentanyl citrate........................................................................ 2461Fenticonazole nitrate .............................................................. 2462Fenugreek ................................................................................ 1354Fermentation, products of ....................................................... 830Ferric chloride hexahydrate................................................... 2463

Ferrous fumarate..................................................................... 2464Ferrous gluconate ................................................................... 2465Ferrous sulfate, dried.............................................................. 2466Ferrous sulfate heptahydrate ................................................. 2467Ferrum metallicum for homoeopathic preparations ......... 1601FET (18F) injection........................................................... 9.3-4797Feverfew................................................................................... 1355Fexofenadine hydrochloride.................................................. 2468Fibrinogen, human................................................................. 2682Fibrin sealant kit ..................................................................... 2469Filgrastim concentrated solution................................... 9.3-4899Films, orodispersible ....................................................... 9.3-4790Finasteride ............................................................................... 2473Fineness, powder (2.9.35.) ....................................................... 362Fish oil, rich in omega-3 acids .............................................. 2474Flavoxate hydrochloride......................................................... 2476Flecainide acetate.................................................................... 2478Fleeceflower root..................................................................... 1356Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.)............................................ 273

Flowability (2.9.16.) .................................................................. 321Flow cytometry (2.7.24.).......................................................... 271FLT (18F) injection .................................................................. 1127Flubendazole ........................................................................... 2479Flucloxacillin magnesium octahydrate ................................ 2480Flucloxacillin sodium............................................................. 2482Fluconazole.............................................................................. 2484Flucytosine............................................................................... 2485Fludarabine phosphate........................................................... 2487Fludeoxyglucose (18F) injection ............................................ 1135Fludrocortisone acetate.......................................................... 2489Flumazenil ............................................................................... 2490Flumazenil (N-[11C]methyl) injection.................................. 1137Flumequine.............................................................................. 2492Flumetasone pivalate.............................................................. 2493Flunarizine dihydrochloride.................................................. 2494Flunitrazepam ......................................................................... 2495Flunixin meglumine for veterinary use ............................... 2496Fluocinolone acetonide.......................................................... 2497Fluocortolone pivalate............................................................ 2500Fluorescein .............................................................................. 2501Fluorescein sodium ................................................................ 2502Fluoride (18F) solution for radiolabelling............................. 1139Fluorides (2.4.5.) ....................................................................... 132Fluorimetry (2.2.21.) .................................................................. 36Fluorocholine (18F) injection................................................. 1139Fluorodeoxythymidine (18F) injection ................................. 1127Fluorodopa (18F) (prepared by electrophilic substitution)injection ................................................................................. 1141

Fluoroethyl-L-tyrosine (18F) injection ........................... 9.3-4797Fluoromisonidazole (18F) injection....................................... 1146Fluorouracil ...................................................................... 9.2-4545Fluoxetine hydrochloride....................................................... 2505Flupentixol dihydrochloride.................................................. 2507Fluphenazine decanoate......................................................... 2509Fluphenazine dihydrochloride .............................................. 2510Fluphenazine enantate ........................................................... 2512Flurazepam monohydrochloride .......................................... 2513Flurbiprofen............................................................................. 2514Fluspirilene .............................................................................. 2516Flutamide................................................................................. 2517Fluticasone propionate........................................................... 2518Flutrimazole ............................................................................ 2520Fluvastatin sodium ................................................................. 2521Fluvoxamine maleate.............................................................. 2523FMISO (18F) injection ............................................................ 1146Foams, cutaneous ..................................................................... 864Foams, intrauterine .................................................................. 862Foams, medicated ..................................................................... 859Foams, rectal ............................................................................. 882Foams, vaginal........................................................................... 889Folic acid.................................................................................. 2524Folinate, calcium..................................................................... 1914

5056 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Follitropin................................................................................ 2526Follitropin concentrated solution ......................................... 2531Foot-and-mouth disease (ruminants) vaccine(inactivated) .......................................................................... 1062

Foreign esters in essential oils (2.8.6.).................................... 284Foreign matter (2.8.2.) ............................................................. 283Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) .................................................................................... 141

Formaldehyde, free (2.4.18.).................................................... 137Formaldehyde solution (35 per cent) ................................... 2537Formoterol fumarate dihydrate............................................. 2537Foscarnet sodium hexahydrate ...................................... 9.2-4546Fosfomycin calcium................................................................ 2541Fosfomycin sodium ................................................................ 2542Fosfomycin trometamol......................................................... 2543Fosinopril sodium .................................................................. 2544Fourstamen stephania root.................................................... 1357Fowl cholera vaccine (inactivated) ....................................... 1063Fowl-pox vaccine (live) .......................................................... 1064Framycetin sulfate .................................................................. 2547Frangula bark .......................................................................... 1358Frangula bark dry extract, standardised.............................. 1359Frankincense, Indian.............................................................. 1392Fraxinus rhynchophylla bark ................................................ 1360Free formaldehyde (2.4.18.)..................................................... 137Freezing point (2.2.18.) .............................................................. 34Fresh bilberry fruit dry extract, refined and standardised.. 1361Friability of granules and spheroids (2.9.41.)........................ 375Friability of uncoated tablets (2.9.7.) ..................................... 312Fructose.................................................................................... 2548Fucus ........................................................................................ 1405Fulvestrant ............................................................................... 2549Fumitory ...........................................................................9.2-4465Functional groups and ions, identification reactions of(2.3.1.) ...................................................................................... 123

Functionality-related characteristics of excipients(5.15.) .............................................................................. 9.2-4411

Fungicidal, bactericidal or yeasticidal activity of antisepticmedicinal products, determination of (5.1.11.) ......... 9.2-4348

Furosemide .............................................................................. 2551Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)for salmonids.................................................................. 9.2-4427

Fusidate, sodium..................................................................... 3579Fusidic acid.............................................................................. 2552

GGabapentin .............................................................................. 2559Gadobutrol monohydrate ............................................... 9.3-4905Gadodiamide hydrate...................................................... 9.1-4165Galactose.................................................................................. 2562Galantamine hydrobromide .................................................. 2563Gallium (67Ga) citrate injection ............................................ 1148Gallium (68Ga) chloride solution for radiolabelling ........... 1148Gallium (68Ga) DOTATOC injection ................................... 1150Gallium (68Ga) edotreotide injection ................................... 1150Ganciclovir .............................................................................. 2566Gargles .............................................................................. 9.3-4788Garlic for homoeopathic preparations................................. 1590Garlic powder.......................................................................... 1364Gas adsorption, specific surface area by (2.9.26.)................. 344Gas chromatography (2.2.28.) ................................................... 44Gas detector tubes (2.1.6.) .............................................. 9.3-4685Gases, carbon dioxide in (2.5.24.) .......................................... 168Gases, carbon monoxide in (2.5.25.)...................................... 169Gases, nitrogen monoxide and nitrogen dioxide in(2.5.26.) .................................................................................... 170

Gases, nitrous oxide in (2.5.35.) ............................................. 176Gases, oxygen in (2.5.27.) ........................................................ 170Gases, water in (2.5.28.) ........................................................... 170Gas-gangrene antitoxin, mixed............................................. 1116Gas-gangrene antitoxin (novyi) ............................................ 1116Gas-gangrene antitoxin (perfringens).................................. 1117

Gas-gangrene antitoxin (septicum)...................................... 1118Gas pycnometric density of solids (2.9.23.)........................... 339Gastro-resistant capsules ................................................ 9.3-4784Gastro-resistant granules ......................................................... 860Gastro-resistant tablets ...................................................9.3-4791Gefitinib ............................................................................ 9.3-4906Gelatin............................................................................... 9.3-4907Gels ............................................................................................. 884Gels for injections..................................................................... 873Gemcitabine hydrochloride................................................... 2570Gemfibrozil.............................................................................. 2571General notices (1.) .........................................................9.2-4275General texts on biological products (5.2.) ........................... 599General texts on microbiology (5.1.) ..................................... 575Gene transfer medicinal products for human use (5.14.).... 739Gentamicin sulfate.................................................................. 2573Gentian root ............................................................................ 1365Gentian tincture...................................................................... 1366Gestodene ................................................................................ 2575Ginger ...................................................................................... 1367Gingival solutions ............................................................ 9.3-4788Ginkgo dry extract, refined and quantified......................... 1368Ginkgo leaf .............................................................................. 1370Ginseng .................................................................................... 1372Ginseng dry extract ................................................................ 1374Glass containers for pharmaceutical use (3.2.1.) .................. 423Glibenclamide ......................................................................... 2577Gliclazide ................................................................................. 2578Glimepiride ............................................................................. 2580Glipizide................................................................................... 2582Glossary (dosage forms) ................................................. 9.2-4423Glucagon, human ................................................................... 2584Glucoheptonate, calcium ....................................................... 1917Glucosamine hydrochloride .................................................. 2585Glucosamine sulfate potassium chloride ............................. 2586Glucosamine sulfate sodium chloride.................................. 2587Glucose.............................................................................. 9.1-4167Glucose, liquid ........................................................................ 2590Glucose, liquid, spray-dried .................................................. 2591Glucose monohydrate ..................................................... 9.1-4168Glutamic acid .......................................................................... 2593Glutathione.............................................................................. 2594Glycan analysis of glycoproteins (2.2.59.) ............................. 103Glycerol .................................................................................... 2595Glycerol (85 per cent) ............................................................ 2597Glycerol dibehenate................................................................ 2598Glycerol distearate .................................................................. 2599Glycerol formal ....................................................................... 2600Glycerol monocaprylate......................................................... 2601Glycerol monocaprylocaprate ............................................... 2602Glycerol monolinoleate.......................................................... 2603Glycerol mono-oleate ............................................................. 2604Glycerol monostearate 40-55 ......................................... 9.2-4551Glycerol triacetate................................................................... 3825Glyceryl trinitrate solution .................................................... 2606Glycine ..................................................................................... 2608Glycoproteins, glycan analysis of (2.2.59.) ............................ 103Glycopyrronium bromide...................................................... 2609Glycyrrhizate ammonium...................................................... 1716Goldenrod................................................................................ 1375Goldenrod, European............................................................. 1376Goldenseal rhizome................................................................ 1378Gonadorelin acetate................................................................ 2611Gonadotrophin, chorionic..................................................... 2613Gonadotrophin, equine serum, for veterinary use............. 2613Goserelin.................................................................................. 2614Grafted copolymer, macrogol poly(vinyl alcohol) ............. 2945Gramicidin .............................................................................. 2616Granisetron hydrochloride.................................................... 2617Granules..................................................................................... 860Granules and powders for oral solutions andsuspensions..................................................................... 9.3-4786

Granules and powders for syrups .................................. 9.3-4787

General Notices (1) apply to all monographs and other texts 5057

Index EUROPEAN PHARMACOPOEIA 9.3

Granules and spheroids, friability of (2.9.41.)....................... 375Granules, coated ....................................................................... 860Granules, effervescent .............................................................. 860Granules, gastro-resistant ........................................................ 860Granules, modified-release...................................................... 860Greater celandine.................................................................... 1380Griseofulvin............................................................................. 2619Guaiacol ................................................................................... 2620Guaifenesin.............................................................................. 2622Guanethidine monosulfate .................................................... 2623Guar.......................................................................................... 1381Guar galactomannan .............................................................. 2623Guidelines for using the test for bacterial endotoxins(5.1.10.) .................................................................................... 593

Guidelines for using the test for sterility (5.1.9.) .................. 592

HHaemagglutinins, anti-A and anti-B (2.6.20.)....................... 213Haematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.) ............................................................................... 269

Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) .................................................................... 274

Haematopoietic stem cells, human....................................... 2682Haemodiafiltration and haemofiltration, solutions for...... 2631Haemodialysis, concentrated solutions for ......................... 2628Haemodialysis solutions, concentrated, water fordiluting................................................................................... 2627

Haemodialysis, solutions for ................................................. 2628Haemofiltration and haemodiafiltration, solutions for...... 2631Haemophilus type b and meningococcal group C conjugatevaccine ..................................................................................... 926

Haemophilus type b (conjugate), diphtheria, tetanus andpertussis (acellular, component) vaccine (adsorbed)......... 908

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component) and poliomyelitis (inactivated)vaccine (adsorbed) ................................................................. 917

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 915

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (whole cell) and poliomyelitis (inactivated) vaccine(adsorbed) ............................................................................... 922

Haemophilus type b conjugate vaccine.................................. 927Haemorrhagic disease vaccine (inactivated), rabbit........... 1092Halofantrine hydrochloride................................................... 2633Haloperidol.............................................................................. 2634Haloperidol decanoate ........................................................... 2636Halothane ................................................................................ 2637Hamamelis bark...................................................................... 1382Hamamelis leaf........................................................................ 1383Hard capsules ................................................................... 9.3-4783Hard fat .................................................................................... 2639Hard fat with additives........................................................... 2640Hard paraffin........................................................................... 3268Harmonisation, pharmacopoeial (5.8.)......................... 9.3-4741Hawthorn berries.................................................................... 1384Hawthorn leaf and flower ...................................................... 1385Hawthorn leaf and flower dry extract .................................. 1386Hawthorn leaf and flower liquid extract, quantified .......... 1387HCP assays (2.6.34.) ........................................................9.1-4041Healthy chicken flocks for the production of inactivatedvaccines for veterinary use (5.2.13.)..................................... 630

Heavy bismuth subnitrate...................................................... 1853Heavy kaolin............................................................................ 2847Heavy magnesium carbonate ................................................ 2955Heavy magnesium oxide........................................................ 2962Heavy metals (2.4.8.) ................................................................ 133Heavy metals in herbal drugs and herbal drug preparations(2.4.27.) .................................................................................... 152

Hedera helix for homoeopathic preparations ..................... 1602Helium ..................................................................................... 2642Heparin, assay of (2.7.5.) ................................................ 9.1-4049

Heparin calcium .............................................................. 9.3-4911Heparin in coagulation factors, assay of (2.7.12.)................. 259Heparins, low-molecular-mass ............................................. 2646Heparin sodium............................................................... 9.3-4913Hepatitis A immunoglobulin, human.................................. 2683Hepatitis A (inactivated, adsorbed) and typhoid polysaccharidevaccine ..................................................................................... 929

Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 930

Hepatitis A vaccine, assay of (2.7.14.) .................................... 262Hepatitis A vaccine (inactivated, adsorbed).......................... 931Hepatitis A vaccine (inactivated, virosome) ......................... 932Hepatitis B immunoglobulin for intravenous administration,human .................................................................................... 2684

Hepatitis B immunoglobulin, human .................................. 2684Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed) ............................................................................... 901

Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ......................... 910

Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) .................................... 915

Hepatitis B vaccine (rDNA) .................................................... 935Hepatitis B vaccine (rDNA), assay of (2.7.15.)...................... 263Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : guidelines ....................................................... 214

Hepatitis type I vaccine (live), viral, duck ........................... 1047Heptaminol hydrochloride .................................................... 2649Herbal drug extracts................................................................. 815Herbal drug extracts, monographs on (information chapter)(5.23.) ....................................................................................... 807

Herbal drug preparations ........................................................ 819Herbal drugs..................................................................... 9.2-4419Herbal drugs and herbal drug preparations, heavy metals in(2.4.27.) .................................................................................... 152

Herbal drugs and herbal drug preparations, high-performancethin-layer chromatography of (2.8.25.)................................ 295

Herbal drugs, determination of aflatoxin B1 in (2.8.18.) ..... 289Herbal drugs, essential oils in (2.8.12.).................................. 285Herbal drugs for homoeopathic preparations..................... 1570Herbal drugs, microscopic examination of (2.8.23)............. 295Herbal drugs : sampling and sample preparation (2.8.20.).. 291Herbal drugs, tannins in (2.8.14.)........................................... 288Herbal drugs, test for aristolochic acids in (2.8.21) ............. 292Herbal medicinal products for oral use and extracts used intheir preparation, microbiological examination (2.6.31.).. 232

Herbal medicinal products for oral use and extracts used intheir preparation, microbiological quality (5.1.8.) ............. 591

Herbal preparations.................................................................. 819Herbal substances ............................................................ 9.2-4419Herbal teas................................................................................. 820Herbal teas, instant................................................................... 820Herpesvirus vaccine (inactivated), equine........................... 1050Herpes zoster (shingles) vaccine (live)................................... 982Hexamidine diisetionate ........................................................ 2650Hexetidine ............................................................................... 2651Hexosamines in polysaccharide vaccines (2.5.20.) ............... 167Hexylresorcinol ....................................................................... 2652Highly purified water ............................................................. 3933High-molecular-mass macrogols.......................................... 2952High-performance thin-layer chromatography of herbal drugsand herbal drug preparations (2.8.25.) ................................ 295

Histamine (2.6.10.) ................................................................... 194Histamine dihydrochloride ................................................... 2653Histamine for homoeopathic preparations .................. 9.1-4118Histaminum for homoeopathic preparations .............. 9.1-4118Histidine .................................................................................. 2654Histidine hydrochloride monohydrate ................................ 2655Homatropine hydrobromide ................................................. 2657Homatropine methylbromide ............................................... 2658Homoeopathic pillules, coated.............................................. 1587Homoeopathic pillules, impregnated ............................ 9.1-4118

5058 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Homoeopathic preparations........................................... 9.1-4117Homoeopathic preparations, Agaricus phalloides for ....... 1588Homoeopathic preparations, Allium sativum for .............. 1590Homoeopathic preparations, ammonium carbonicumfor .................................................................................... 9.3-4827

Homoeopathic preparations, Anacardium for.................... 1591Homoeopathic preparations, Apis for.................................. 1592Homoeopathic preparations, arsenicum album for ........... 1593Homoeopathic preparations, aurum chloratum natronatumfor ........................................................................................... 1593

Homoeopathic preparations, barium chloratum for.......... 1594Homoeopathic preparations, Belladonna for............... 9.2-4492Homoeopathic preparations, cadmium sulfuricum for..... 1596Homoeopathic preparations, calcium iodatum for ............ 1596Homoeopathic preparations, Cocculus for ......................... 1597Homoeopathic preparations, Crocus for ............................. 1599Homoeopathic preparations, cuprum aceticum for........... 1599Homoeopathic preparations, cuprum metallicum for....... 1600Homoeopathic preparations, ferrum metallicum for ........ 1601Homoeopathic preparations, hedera helix for .................... 1602Homoeopathic preparations, herbal drugs for.................... 1570Homoeopathic preparations, hydrastis canadensis for ...... 1603Homoeopathic preparations, hyoscyamus for .................... 1604Homoeopathic preparations, hypericum for....................... 1605Homoeopathic preparations, kalium bichromicum for..... 1608Homoeopathic preparations, magnesium fluoratum for ... 1609Homoeopathic preparations, magnesium phosphoricumfor ........................................................................................... 1609

Homoeopathic preparations, mother tinctures for ............ 1571Homoeopathic preparations, Nux-vomica for ............. 9.3-4829Homoeopathic preparations, petroleum rectificatum for.. 1612Homoeopathic preparations, pillules for ............................. 1586Homoeopathic preparations, selenium for................... 9.2-4494Homoeopathic preparations, Staphysagria for.................... 1612Homoeopathic preparations, sulfur for ............................... 1614Homoeopathic preparations, Urtica dioica for ................... 1614Homoeopathic stocks (methods of preparation of) andpotentisation .................................................................. 9.2-4479

Homoepathic preparations, Ignatia for......................... 9.3-4827Honey ....................................................................................... 2659Honey bee for homoeopathic preparations......................... 1592Hop strobile............................................................................. 1388Horse-chestnut ........................................................................ 1389Horse-chestnut dry extract, standardised............................ 1390Host-cell protein assays (2.6.34.) ................................... 9.1-4041Human α-1-proteinase inhibitor .......................................... 2694Human α-1-proteinase inhibitor, assay of (2.7.32.).............. 278Human albumin injection, iodinated (125I) ......................... 1152Human albumin solution ...................................................... 2660Human anti-D immunoglobulin .......................................... 2662Human anti-D immunoglobulin, assay of (2.7.13.) ............. 260Human anti-D immunoglobulin for intravenousadministration....................................................................... 2663

Human antithrombin III, assay of (2.7.17.)........................... 265Human antithrombin III concentrate .................................. 2664Human C1-esterase inhibitor................................................ 2665Human C1-esterase inhibitor, assay of (2.7.34.) ................... 278Human coagulation factor II, assay of (2.7.18.).................... 266Human coagulation factor IX ............................................... 2674Human coagulation factor IX, assay of (2.7.11.) .................. 259Human coagulation factor IX (rDNA) concentratedsolution ........................................................................... 9.3-4915

Human coagulation factor IX (rDNA) powder for solution forinjection .......................................................................... 9.3-4920

Human coagulation factor VII.............................................. 2666Human coagulation factor VIIa (rDNA) concentratedsolution .................................................................................. 2668

Human coagulation factor VII, assay of (2.7.10.)................. 258Human coagulation factor VIII ............................................ 2672Human coagulation factor VIII, assay of (2.7.4.) ................. 246Human coagulation factor VIII (rDNA) ............................. 2673Human coagulation factor X, assay of (2.7.19.) .................... 266Human coagulation factor XI ............................................... 2681

Human coagulation factor XI, assay of (2.7.22.) .................. 269Human fibrinogen .................................................................. 2682Human glucagon..................................................................... 2584Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) .................................................................... 274

Human haematopoietic stem cells........................................ 2682Human hepatitis A immunoglobulin................................... 2683Human hepatitis B immunoglobulin ................................... 2684Human hepatitis B immunoglobulin for intravenousadministration....................................................................... 2684

Human insulin ........................................................................ 2768Human measles immunoglobulin ........................................ 2685Human normal immunoglobulin for intramuscularadministration....................................................................... 2685

Human normal immunoglobulin for intravenousadministration....................................................................... 2687

Human normal immunoglobulin for subcutaneousadministration....................................................................... 2689

Human papillomavirus vaccine (rDNA) ............................... 936Human plasma for fractionation .......................................... 2691Human plasma (pooled and treated for virusinactivation) ................................................................... 9.2-4555

Human plasmin inhibitor, assay of (2.7.25.) ......................... 272Human protein C, assay of (2.7.30.)....................................... 276Human protein S, assay of (2.7.31.)........................................ 277Human prothrombin complex .............................................. 2695Human rabies immunoglobulin ........................................... 2696Human rubella immunoglobulin ......................................... 2698Human tetanus immunoglobulin ......................................... 2698Human varicella immunoglobulin ....................................... 2700Human varicella immunoglobulin for intravenousadministration....................................................................... 2700

Human von Willebrand factor .............................................. 2701Human von Willebrand factor, assay of (2.7.21.) ................. 268Hyaluronate, sodium.............................................................. 3583Hyaluronidase ........................................................................ 2702Hydralazine hydrochloride............................................. 9.2-4557Hydrastis canadensis for homoeopathic preparations ....... 1603Hydrochloric acid, concentrated .......................................... 2704Hydrochloric acid, dilute ....................................................... 2704Hydrochlorothiazide .............................................................. 2705Hydrocodone hydrogen tartrate 2.5-hydrate ...................... 2706Hydrocortisone ....................................................................... 2708Hydrocortisone acetate .......................................................... 2711Hydrocortisone hydrogen succinate..................................... 2713Hydrogenated arachis oil ....................................................... 1752Hydrogenated castor oil ......................................................... 1966Hydrogenated cottonseed oil................................................. 2173Hydrogenated soya-bean oil.................................................. 3630Hydrogenated vegetable oils, nickel in (2.4.31.) ................... 157Hydrogenated wool fat........................................................... 3943Hydrogen peroxide solution (30 per cent) .......................... 2715Hydrogen peroxide solution (3 per cent) ............................ 2715Hydromorphone hydrochloride............................................ 2716Hydrophobic colloidal silica.................................................. 3551Hydrous wool fat .................................................................... 3944Hydroxocobalamin acetate .................................................... 2717Hydroxocobalamin chloride.................................................. 2718Hydroxocobalamin sulfate..................................................... 2719Hydroxycarbamide ................................................................. 2720Hydroxychloroquine sulfate ........................................... 9.3-4922Hydroxyethylcellulose ..................................................... 9.3-4924Hydroxyethylmethylcellulose ................................................ 3037Hydroxyethyl salicylate .......................................................... 2723Hydroxyethyl starches ............................................................ 3649Hydroxyl value (2.5.3.)............................................................. 161Hydroxypropylbetadex........................................................... 2725Hydroxypropylcellulose ......................................................... 2727Hydroxypropylcellulose, low-substituted ............................ 2729Hydroxypropylmethylcellulose ............................................. 2738Hydroxypropylmethylcellulose phthalate ............................ 2740Hydroxypropyl starch............................................................. 3645Hydroxypropyl starch, pregelatinised .................................. 3647

General Notices (1) apply to all monographs and other texts 5059

Index EUROPEAN PHARMACOPOEIA 9.3

Hydroxyzine hydrochloride................................................... 2730Hymecromone......................................................................... 2731Hymenoptera venoms for allergen products....................... 2732Hyoscine .................................................................................. 2733Hyoscine butylbromide.......................................................... 2734Hyoscine hydrobromide ........................................................ 2735Hyoscyamine sulfate............................................................... 2737Hyoscyamus for homoeopathic preparations ..................... 1604Hypericum............................................................................... 1526Hypericum for homoeopathic preparations........................ 1605Hypromellose .......................................................................... 2738Hypromellose phthalate ......................................................... 2740

IIbuprofen ................................................................................. 2745Iceland moss............................................................................ 1392ICH (5.8.).......................................................................... 9.3-4741Ichthammol ............................................................................. 2747Identification (2.3.) ................................................................... 123Identification and control of residual solvents (2.4.24.) ...... 146Identification of fatty oils by thin-layer chromatography(2.3.2.) ...................................................................................... 126

Identification of phenothiazines by thin-layer chromatography(2.3.3.) ...................................................................................... 127

Identification reactions of ions and functional groups(2.3.1.) ...................................................................................... 123

Idoxuridine .............................................................................. 2748Ifosfamide ................................................................................ 2749Ignatia for homoeopathic preparations ........................ 9.3-4827Imatinib mesilate ............................................................. 9.2-4561Imipenem monohydrate ........................................................ 2753Imipramine hydrochloride .................................................... 2754Immunochemical methods (2.7.1.) ........................................ 239Immunoglobulin for human use, anti-T lymphocyte,animal .................................................................................... 1741

Immunoglobulin for intramuscular administration, humannormal.................................................................................... 2685

Immunoglobulin for intravenous administration, humananti-D ..................................................................................... 2663

Immunoglobulin for intravenous administration, humanhepatitis B.............................................................................. 2684

Immunoglobulin for intravenous administration, humannormal.................................................................................... 2687

Immunoglobulin for intravenous administration, humanvaricella .................................................................................. 2700

Immunoglobulin for subcutaneous administration, humannormal.................................................................................... 2689

Immunoglobulin, human anti-D.......................................... 2662Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 260Immunoglobulin, human hepatitis A .................................. 2683Immunoglobulin, human hepatitis B................................... 2684Immunoglobulin, human measles ........................................ 2685Immunoglobulin, human rabies ........................................... 2696Immunoglobulin, human rubella ......................................... 2698Immunoglobulin, human tetanus......................................... 2698Immunoglobulin, human varicella ....................................... 2700Immunoglobulin, test for anticomplementary activity of(2.6.17.) ........................................................................... 9.3-4713

Immunoglobulin, test for Fc function of (2.7.9.).........9.3-4724Immunological veterinary medicinal products, substances ofanimal origin for the production of (5.2.5.)........................ 608

Immunonephelometry for vaccine component assay(2.7.35.) .................................................................................... 279

Immunosera and vaccines, phenol in (2.5.15.) ..................... 166Immunosera and vaccines, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 612

Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 610

Immunosera for human use, animal ...................................... 821Immunosera for veterinary use............................................... 823Immunosera for veterinary use, evaluation of the safety ofeach batch (5.2.9.)................................................................... 625

Implants ..................................................................................... 873Impurities in substances for pharmaceutical use, control of(5.10.) ....................................................................................... 723

Inactivated vaccines for veterinary use, healthy chicken flocksfor the production of (5.2.13.) .............................................. 630

Indapamide.............................................................................. 2755Indian frankincense................................................................ 1392Indicators, approximate pH of solutions (2.2.4.) .................... 25Indigo plant leaf ...................................................................... 1393Indinavir sulfate ...................................................................... 2757Indium (111In) chloride solution ........................................... 1153Indium (111In) oxine solution ................................................ 1154Indium (111In) pentetate injection ........................................ 1154Indometacin ............................................................................ 2759Inductively coupled plasma-atomic emission spectrometry(2.2.57.) .................................................................................... 100

Inductively coupled plasma-mass spectrometry (2.2.58.) ... 101Infectious bovine rhinotracheitis vaccine (inactivated)..... 1067Infectious bovine rhinotracheitis vaccine (live).................. 1068Infectious bronchitis vaccine (inactivated), avian .............. 1007Infectious bronchitis vaccine (live), avian ........................... 1008Infectious bursal disease vaccine (inactivated), avian........ 1010Infectious bursal disease vaccine (live), avian..................... 1011Infectious chicken anaemia vaccine (live) ........................... 1069Infectious encephalomyelitis vaccine (live), avian.............. 1013Infectious enteritis vaccine (inactivated), feline ................. 1056Infectious enteritis vaccine (live), feline .............................. 1057Infectious laryngotracheitis vaccine (live), avian ............... 1014Infectious rhinotracheitis vaccine (live), turkey ................. 1107Influenza vaccine (inactivated), equine ............................... 1051Influenza vaccine (inactivated), porcine.............................. 1087Influenza vaccine (live, nasal) ................................................. 939Influenza vaccine (split virion, inactivated) .......................... 942Influenza vaccine (surface antigen, inactivated)................... 943Influenza vaccine (surface antigen, inactivated, prepared incell cultures) ............................................................................ 945

Influenza vaccine (surface antigen, inactivated, virosome).. 947Influenza vaccine (whole virion, inactivated) ....................... 949Influenza vaccine (whole virion, inactivated, prepared in cellcultures) ................................................................................... 950

Infrared absorption spectrophotometry (2.2.24.)................... 39Infusions .................................................................................... 872Inhalation gas, krypton (81mKr)............................................. 1159Inhalation powders................................................................... 878Inhalation, preparations for .................................................... 875Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 323

Injectable insulin preparations.............................................. 2776Injections ................................................................................... 871Injections, gels for..................................................................... 873Injections or infusions, concentrates for ............................... 872Injections or infusions, powders for....................................... 872Inositol, myo- .......................................................................... 2761Inserts, ophthalmic................................................................... 858Instant herbal teas .................................................................... 820Insulin aspart........................................................................... 2762Insulin, bovine ................................................................. 9.3-4929Insulin glargine ....................................................................... 2766Insulin, human........................................................................ 2768Insulin injection, biphasic ..................................................... 2770Insulin injection, biphasic isophane..................................... 2770Insulin injection, isophane .................................................... 2771Insulin injection, soluble ....................................................... 2771Insulin lispro ........................................................................... 2771Insulin, porcine ................................................................ 9.3-4931Insulin preparations, injectable............................................. 2776Insulin zinc injectable suspension ........................................ 2778Insulin zinc injectable suspension (amorphous) ................ 2779Insulin zinc injectable suspension (crystalline) .................. 2779Interferon alfa-2 concentrated solution ............................... 2780Interferon beta-1a concentrated solution ............................ 2782Interferon gamma-1b concentrated solution ...................... 2785Interferons, assay of (5.6.)........................................................ 689

5060 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

International System (SI) units (1.) ............................... 9.2-4275Intramammary preparations for veterinary use ................... 861Intraruminal delivery systems ....................................... 9.3-4785Intrauterine capsules ................................................................ 862Intrauterine foams .................................................................... 862Intrauterine preparations for veterinary use ......................... 862Intrauterine solutions, suspensions ........................................ 862Intrauterine sticks ..................................................................... 862Intrauterine tablets ................................................................... 862Intrinsic dissolution (2.9.29.) .................................................. 347In vitro method(s) for the quality control of vaccines,substitution of in vivo method(s) by (5.2.14.)............ 9.3-4737

In vivo assay of poliomyelitis vaccine (inactivated)(2.7.20.) .................................................................................... 267

Iobenguane (123I) injection .................................................... 1155Iobenguane (131I) injection for diagnostic use..................... 1156Iobenguane (131I) injection for therapeutic use................... 1157Iobenguane sulfate for radiopharmaceutical preparations.. 9.2-4435

Iodinated (125I) human albumin injection ........................... 1152Iodinated povidone ................................................................ 3394Iodine ....................................................................................... 2788Iodine value (2.5.4.).................................................................. 161Iodixanol .................................................................................. 2788Iodohippurate (sodium) dihydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4438

Iodomethylnorcholesterol (131I) injection............................ 1159Iohexol...................................................................................... 2791Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)............................................. 60

Ions and functional groups, identification reactions of(2.3.1.) ...................................................................................... 123

Ion-selective electrodes, potentiometric determination ofionic concentration (2.2.36.) ................................................... 60

Iopamidol................................................................................. 2795Iopanoic acid ........................................................................... 2797Iopromide ................................................................................ 2798Iotrolan .................................................................................... 2801Ioxaglic acid............................................................................. 2803Ipecacuanha liquid extract, standardised ............................ 1395Ipecacuanha, prepared ........................................................... 1395Ipecacuanha root .................................................................... 1397Ipecacuanha tincture, standardised...................................... 1398Ipratropium bromide ............................................................. 2805Irbesartan................................................................................. 2807Irinotecan hydrochloride trihydrate..............................9.3-4933Iron (2.4.9.)................................................................................ 136Iron for homoeopathic preparations.................................... 1601Irrigation, preparations for...................................................... 880Isatis root ................................................................................. 1399Isoconazole .............................................................................. 2810Isoconazole nitrate.................................................................. 2811Isoelectric focusing (2.2.54.) ..................................................... 89Isoflurane ................................................................................. 2813Isoleucine................................................................................. 2814Isomalt ..................................................................................... 2815Isoniazid................................................................................... 2817Isophane insulin injection ..................................................... 2771Isoprenaline hydrochloride ................................................... 2817Isoprenaline sulfate................................................................. 2818Isopropyl alcohol .................................................................... 2819Isopropyl isostearate........................................................ 9.2-4563Isopropyl myristate................................................................. 2820Isopropyl palmitate................................................................. 2821Isosorbide dinitrate, diluted ................................................. 2821Isosorbide mononitrate, diluted .......................................... 2823Isotretinoin .............................................................................. 2825Isoxsuprine hydrochloride..................................................... 2826Ispaghula husk ........................................................................ 1400Ispaghula seed ......................................................................... 1400Isradipine ................................................................................. 2828Itraconazole ............................................................................. 2829Ivermectin................................................................................ 2832

Ivy leaf ...................................................................................... 1401

JJavanese turmeric.................................................................... 1544Java tea ..................................................................................... 1402Josamycin................................................................................. 2837Josamycin propionate............................................................. 2839Juniper...................................................................................... 1404Juniper oil ................................................................................ 1404

KKalium bichromicum for homoeopathic preparations ...... 1608Kanamycin acid sulfate .......................................................... 2845Kanamycin monosulfate ........................................................ 2846Kaolin, heavy........................................................................... 2847Kelp........................................................................................... 1405Ketamine hydrochloride ........................................................ 2847Ketobemidone hydrochloride ............................................... 2848Ketoconazole ........................................................................... 2849Ketoprofen ............................................................................... 2851Ketorolac trometamol ............................................................ 2853Ketotifen hydrogen fumarate ................................................ 2854Knotgrass ................................................................................. 1406Krypton (81mKr) inhalation gas ............................................. 1159Kudzuvine root ................................................................9.3-4816Kudzuvine root, Thomson.............................................. 9.3-4820

LLabetalol hydrochloride......................................................... 2859Lactic acid................................................................................ 2860Lactic acid, (S)- ....................................................................... 2861Lactitol monohydrate ...................................................... 9.3-4939Lactobionic acid...................................................................... 2863Lactose .............................................................................. 9.3-4940Lactose monohydrate ...................................................... 9.3-4942Lactulose ........................................................................... 9.3-4943Lactulose, liquid...................................................................... 2869Lamivudine.............................................................................. 2871Lamotrigine ............................................................................. 2873Lansoprazole .................................................................... 9.3-4945Largehead atractylodes rhizome ........................................... 1260Laryngotracheitis vaccine (live), infectious, avian ............. 1014Laser light diffraction, particle size analysis by (2.9.31.) .... 349Laurilsulfate, sodium....................................................... 9.1-4200Lauromacrogol 400................................................................. 2876Lauroyl macrogolglycerides............................................ 9.1-4173Lavender flower ...................................................................... 1408Lavender oil ............................................................................. 1410Lavender oil, spike.................................................................. 1525Lead in sugars (2.4.10.) ............................................................ 136Leflunomide ............................................................................ 2879Lemon oil................................................................................. 1411Lemon verbena leaf ................................................................ 1412Leptospirosis vaccine (inactivated), bovine......................... 1019Leptospirosis vaccine (inactivated), canine ......................... 1030Letrozole .................................................................................. 2880Leucine..................................................................................... 2881Leukaemia vaccine (inactivated), feline............................... 1058Leuprorelin .............................................................................. 2883Levamisole for veterinary use ............................................... 2885Levamisole hydrochloride ..................................................... 2886Levetiracetam.......................................................................... 2887Levocabastine hydrochloride ......................................... 9.3-4946Levocarnitine........................................................................... 2890Levodopa ................................................................................. 2892Levodropropizine.................................................................... 2893Levofolinate pentahydrate, calcium...................................... 1926Levomenthol............................................................................ 2894Levomepromazine hydrochloride......................................... 2895Levomepromazine maleate.................................................... 2896Levomethadone hydrochloride ............................................. 2897Levonorgestrel......................................................................... 2899

General Notices (1) apply to all monographs and other texts 5061

Index EUROPEAN PHARMACOPOEIA 9.3

Levothyroxine sodium ........................................................... 2902Levulinate dihydrate, calcium ............................................... 1928Lidocaine ................................................................................. 2903Lidocaine hydrochloride........................................................ 2905Light liquid paraffin ............................................................... 3269Light magnesium carbonate .................................................. 2956Light magnesium oxide.......................................................... 2963Lime flower.............................................................................. 1414Limit tests (2.4.) ........................................................................ 131Limit tests, standard solutions for (4.1.2.) ............................. 555Limit tests, standard solutions for (4.1.2.) .................... 9.2-4324Limit tests, standard solutions for (4.1.2.) .................... 9.3-4730Lincomycin hydrochloride .................................................... 2906Linen thread, sterile, in distributor for veterinary use ..... 1220Linoleoyl macrogolglycerides......................................... 9.1-4174Linseed ..................................................................................... 1415Linseed oil, virgin ................................................................... 2908Liothyronine sodium.............................................................. 2909Lipophilic solid dosage forms, dissolution test for(2.9.42.) .................................................................................... 377

Liquid chromatography (2.2.29.) .............................................. 46Liquid extraction preparations ............................................... 817Liquid (fluid) extracts .............................................................. 817Liquid glucose ......................................................................... 2590Liquid glucose, spray-dried ................................................... 2591Liquid lactulose....................................................................... 2869Liquid maltitol ........................................................................ 2974Liquid paraffin ........................................................................ 3269Liquid preparations for cutaneous application ..................... 864Liquid preparations for cutaneous application,veterinary........................................................................ 9.3-4792

Liquid preparations for oral use .................................... 9.3-4785Liquids, clarity and degree of opalescence of (2.2.1.) .. 9.2-4285Liquid sorbitol (crystallising)................................................ 3626Liquid sorbitol (non-crystallising) ....................................... 3627Liquid sorbitol, partially dehydrated.................................... 3628Liquorice dry extract for flavouring purposes .................... 1415Liquorice root ......................................................................... 1416Lisinopril dihydrate ................................................................ 2910Lithium carbonate .................................................................. 2912Lithium citrate ........................................................................ 2913L-Methionine ([11C]methyl) injection .................................. 1161Lobeline hydrochloride.......................................................... 2913Lomustine ................................................................................ 2914Long pepper ............................................................................ 1417Loosestrife ............................................................................... 1419Loperamide hydrochloride.................................................... 2915Loperamide oxide monohydrate........................................... 2917Lopinavir.................................................................................. 2918Loratadine................................................................................ 2922Lorazepam ............................................................................... 2924Losartan potassium ................................................................ 2925Loss on drying (2.2.32.) ............................................................. 53Loss on drying of extracts (2.8.17.) ........................................ 289Lovage root .............................................................................. 1420Lovastatin ................................................................................ 2927Low-molecular-mass heparins.............................................. 2646Low-substituted hydroxypropylcellulose ............................. 2729Lozenges and pastilles ..................................................... 9.3-4789Lozenges, compressed ..................................................... 9.3-4789Lubricant, silicone oil (3.1.8.).................................................. 408Lufenuron for veterinary use ................................................ 2929Lutetium (177Lu) solution for radiolabelling................. 9.3-4799Lycopus lucidus herb....................................................... 9.1-4105Lymecycline............................................................................. 2930Lynestrenol .............................................................................. 2932Lyophilisates, oral ............................................................ 9.3-4792Lysine acetate .......................................................................... 2933Lysine hydrochloride.............................................................. 2935

MMacrogol 15 hydroxystearate ................................................ 2939

Macrogol 20 glycerol monostearate...................................... 2940Macrogol 30 dipolyhydroxystearate ..................................... 2941Macrogol 40 sorbitol heptaoleate.......................................... 2941Macrogol 6 glycerol caprylocaprate...................................... 2939Macrogol cetostearyl ether .................................................... 2942Macrogolglycerol cocoates..................................................... 2948Macrogolglycerol hydroxystearate ........................................ 2949Macrogolglycerol ricinoleate ................................................. 2950Macrogol isotridecyl ether..................................................... 2943Macrogol lauryl ether............................................................. 2943Macrogol oleate....................................................................... 2944Macrogol oleyl ether............................................................... 2945Macrogol poly(vinyl alcohol) grafted copolymer ............... 2945Macrogols ................................................................................ 2950Macrogols, high-molecular-mass ......................................... 2952Macrogol stearate.................................................................... 2947Macrogol stearyl ether ........................................................... 2947Magaldrate ............................................................................... 2953Magnesium (2.4.6.)................................................................... 132Magnesium acetate tetrahydrate ........................................... 2954Magnesium aluminium silicate...................................... 9.3-4839Magnesium and alkaline-earth metals (2.4.7.)...................... 133Magnesium aspartate dihydrate..................................... 9.3-4951Magnesium carbonate, heavy................................................ 2955Magnesium carbonate, light .................................................. 2956Magnesium chloride 4.5-hydrate .......................................... 2957Magnesium chloride hexahydrate ........................................ 2957Magnesium citrate .................................................................. 2958Magnesium citrate dodecahydrate........................................ 2959Magnesium citrate nonahydrate ........................................... 2959Magnesium fluoratum for homoeopathic preparations..... 1609Magnesium gluconate ............................................................ 2960Magnesium glycerophosphate............................................... 2960Magnesium hydroxide............................................................ 2961Magnesium lactate dihydrate ................................................ 2961Magnesium oxide, heavy ....................................................... 2962Magnesium oxide, light.......................................................... 2963Magnesium peroxide.............................................................. 2963Magnesium phosphoricum for homoeopathicpreparations .......................................................................... 1609

Magnesium pidolate ............................................................... 2964Magnesium stearate................................................................ 2965Magnesium sulfate heptahydrate .......................................... 2968Magnesium trisilicate ............................................................. 2968Magnolia biondii flower bud.......................................... 9.3-4817Magnolia officinalis bark ................................................ 9.2-4467Magnolia officinalis flower ............................................. 9.3-4819Maize oil, refined .................................................................... 2969Maize starch ............................................................................ 2969Malathion................................................................................. 2970Maleic acid............................................................................... 2971Malic acid ................................................................................ 2972Mallow flower.......................................................................... 1424Mallow leaf .............................................................................. 1425Maltitol..................................................................................... 2973Maltitol, liquid ........................................................................ 2974Maltodextrin............................................................................ 2975Mandarin epicarp and mesocarp.......................................... 1426Mandarin oil............................................................................ 1428Manganese gluconate ............................................................. 2976Manganese glycerophosphate, hydrated .............................. 2976Manganese sulfate monohydrate ................................... 9.2-4567Mannheimia vaccine (inactivated) for cattle....................... 1071Mannheimia vaccine (inactivated) for sheep ...................... 1072Mannitol ........................................................................... 9.2-4567Maprotiline hydrochloride .................................................... 2980Marbofloxacin for veterinary use ......................................... 2981Marek’s disease vaccine (live) ................................................ 1073Marshmallow leaf ................................................................... 1429Marshmallow root .................................................................. 1430Mass spectrometry (2.2.43.) ...................................................... 71Mass spectrometry, inductively coupled plasma- (2.2.58.).. 101

5062 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Mass uniformity of delivered doses from multidose containers(2.9.27.) .................................................................................... 347

Mass uniformity of single-dose preparations (2.9.5.) .......... 311Mastic ....................................................................................... 1430Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) .................................................................................... 410

Materials based on non-plasticised poly(vinyl chloride) forcontainers for solid dosage forms for oral administration(3.1.11.) .................................................................................... 412

Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) .................................................................................... 416

Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) ................................................................................... 391

Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.)............................................................. 393

Materials for containers for human blood and bloodcomponents (3.1.1.)................................................................ 391

Materials used for the manufacture of containers (3.1.)...... 391Matricaria flower .................................................................... 1431Matricaria liquid extract ........................................................ 1433Matricaria oil........................................................................... 1434Meadowsweet .......................................................................... 1436Measles immunoglobulin, human ........................................ 2685Measles, mumps and rubella vaccine (live)........................... 952Measles, mumps, rubella and varicella vaccine (live) .......... 953Measles vaccine (live)............................................................... 955Measurement and detection of radioactivity (2.2.66.) ......... 113Measurement of consistency by penetrometry (2.9.9.)........ 313Mebendazole ........................................................................... 2983Meclozine dihydrochloride.................................................... 2984Medicated chewing gums ............................................... 9.3-4784Medicated chewing gums, dissolution test for (2.9.25.)....... 340Medicated feeding stuffs for veterinary use, premixes for .. 875Medicated foams....................................................................... 859Medicated plasters .................................................................... 884Medicated tampons .................................................................. 887Medicated vaginal tampons..................................................... 889Medicinal air ........................................................................... 1653Medicinal air, synthetic.......................................................... 1655Medium-chain triglycerides .................................................. 3839Medronic acid for radiopharmaceutical preparations.. 9.2-4437Medroxyprogesterone acetate................................................ 2985Mefenamic acid....................................................................... 2987Mefloquine hydrochloride..................................................... 2989Megestrol acetate .................................................................... 2990Meglumine............................................................................... 2992Meldonium dihydrate............................................................. 2993Melilot ...................................................................................... 1437Melissa leaf .............................................................................. 1438Melissa leaf dry extract .......................................................... 1439Meloxicam ............................................................................... 2994Melphalan ................................................................................ 2996Melting point - capillary method (2.2.14.) ................... 9.1-4037Melting point - instantaneous method (2.2.16.) ..................... 33Melting point - open capillary method (2.2.15.) .................... 32Menadione............................................................................... 2998Meningococcal group C and haemophilus type b conjugatevaccine ..................................................................................... 926

Meningococcal group C conjugate vaccine ........................... 956Meningococcal polysaccharide vaccine ................................. 958Menthol, racemic .................................................................... 2998Mepivacaine hydrochloride ................................................... 2999Meprobamate .......................................................................... 3001Mepyramine maleate.............................................................. 3001Mercaptopurine ...................................................................... 3003Mercuric chloride ................................................................... 3003Mercury porosimetry, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 352

Meropenem trihydrate ........................................................... 3004

Mesalazine ............................................................................... 3005Mesna ................................................................................ 9.2-4569Mesterolone ............................................................................. 3009Mestranol ................................................................................. 3010Metabisulfite, potassium ........................................................ 3386Metabisulfite, sodium............................................................. 3591Metacresol................................................................................ 3011Metal catalyst or metal reagent residues (5.20.)........... 9.3-4759Metamizole sodium monohydrate........................................ 3012Metered-dose preparations for inhalation, non-pressurised............................................................................... 878

Metered-dose preparations for inhalation, pressurised ....... 876Metformin hydrochloride...................................................... 3014Methacrylate copolymer, basic butylated ............................ 1798Methacrylic acid - ethyl acrylate copolymer (1:1).............. 3015Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ............................................................................. 3017

Methacrylic acid - methyl methacrylate copolymer (1:1).. 3018Methacrylic acid - methyl methacrylate copolymer (1:2).. 3019Methadone hydrochloride ..................................................... 3020Methane ................................................................................... 3021Methane intermix (2 per cent) in nitrogen .................. 9.3-4953Methanesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.38.)................................................................. 177

Methanesulfonic acid, methanesulfonyl chloride in(2.5.39.) .................................................................................... 178

Methanesulfonic acid, methyl, ethyl and isopropylmethanesulfonate in (2.5.37.)................................................ 176

Methanesulfonyl chloride in methanesulfonic acid(2.5.39.) .................................................................................... 178

Methanol.................................................................................. 3022Methanol and 2-propanol, test for (2.9.11.) .......................... 318Methenamine .......................................................................... 3023Methionine .............................................................................. 3024Methionine ([11C]methyl) injection, L- ................................ 1161Methionine, DL- ...................................................................... 3025Methods in pharmacognosy (2.8.).......................................... 283Methods of preparation of homoeopathic stocks andpotentisation .................................................................. 9.2-4479

Methods of preparation of sterile products (5.1.1.) .... 9.2-4333Methotrexate ........................................................................... 3026Methylcellulose ....................................................................... 3031Methyldopa.............................................................................. 3033Methylene blue........................................................................ 3049Methylene chloride................................................................. 3034Methylergometrine maleate .................................................. 3035Methyl, ethyl and isopropyl benzenesulfonate in activesubstances (2.5.41).................................................................. 180

Methyl, ethyl and isopropyl methanesulfonate in activesubstances (2.5.38.)................................................................. 177

Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid (2.5.37.) .............................................. 176

Methyl, ethyl and isopropyl toluenesulfonate in activesubstances (2.5.40.)................................................................. 179

Methylhydroxyethylcellulose................................................. 3037Methyl methacrylate – methacrylic acid copolymer (1:1).. 3018Methyl methacrylate - methacrylic acid copolymer (1:2).. 3019Methyl nicotinate.................................................................... 3028Methyl parahydroxybenzoate................................................ 3029Methyl parahydroxybenzoate, sodium................................. 3591Methylpentoses in polysaccharide vaccines (2.5.21.) ........... 167Methylphenidate hydrochloride ........................................... 3037Methylphenobarbital .............................................................. 3039Methylprednisolone................................................................ 3040Methylprednisolone acetate................................................... 3042Methylprednisolone hydrogen succinate ............................. 3044Methylpyrrolidone, N- ........................................................... 3046Methylrosanilinium chloride ................................................ 3047Methyl salicylate ..................................................................... 3030Methyltestosterone ................................................................. 3048Methylthioninium chloride ................................................... 3049Metixene hydrochloride......................................................... 3050Metoclopramide...................................................................... 3051

General Notices (1) apply to all monographs and other texts 5063

Index EUROPEAN PHARMACOPOEIA 9.3

Metoclopramide hydrochloride ............................................ 3053Metolazone .............................................................................. 3053Metoprolol succinate .............................................................. 3055Metoprolol tartrate ................................................................. 3056Metrifonate .............................................................................. 3058Metronidazole ......................................................................... 3059Metronidazole benzoate......................................................... 3060Mexiletine hydrochloride ...................................................... 3062Mianserin hydrochloride ....................................................... 3063Miconazole .............................................................................. 3064Miconazole nitrate.................................................................. 3066Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) .............................................. 195

Microbiological assay of antibiotics (2.7.2.) ................. 9.3-4719Microbiological examination of cell-based preparations(2.6.27.) ........................................................................... 9.2-4297

Microbiological examination of herbal medicinal products fororal use and extracts used in their preparation (2.6.31.)... 232

Microbiological examination of non-sterile products :microbial enumeration tests (2.6.12.) .................................. 195

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ..................................... 199

Microbiological quality, alternative methods for control of(5.1.6.) ............................................................................. 9.2-4339

Microbiological quality of herbal medicinal products for oraluse and extracts used in their preparation (5.1.8.)............. 591

Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.1.4.) ...................................................................................... 579

Microbiology, general texts on (5.1.) ..................................... 575Microcalorimetry and solution calorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 109

Microcrystalline cellulose ...................................................... 2010Microcrystalline cellulose and carmellose sodium ............ 3068Micro determination of water (2.5.32.).................................. 172Microscopic examination of herbal drugs (2.8.23) .............. 295Microscopy, optical (2.9.37.) ................................................... 365Midazolam............................................................................... 3069Milbemycin oxime for veterinary use ........................... 9.2-4570Milk thistle dry extract, refined and standardised ............. 1440Milk thistle fruit...................................................................... 1441Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.)...................................................................... 613

Minocycline hydrochloride dihydrate........................... 9.2-4573Minoxidil ................................................................................. 3072Mint oil, partly dementholised ............................................. 1443Mirtazapine ............................................................................. 3074Misoprostol.............................................................................. 3075Mites for allergen products ................................................... 3077Mitomycin ............................................................................... 3078Mitoxantrone hydrochloride ................................................. 3079Modafinil ................................................................................. 3081Modified-release capsules ............................................... 9.3-4784Modified-release granules........................................................ 860Modified-release tablets .................................................. 9.3-4791Mofetil mycophenolate .......................................................... 3104Molecular mass distribution in dextrans (2.2.39.).................. 62Molgramostim concentrated solution.................................. 3082Molsidomine ........................................................................... 3084Molybdate dihydrate, sodium ............................................... 3592Mometasone furoate............................................................... 3086Monoclonal antibodies for human use .................................. 826Monocyte-activation test (2.6.30.) ................................. 9.2-4299Monographs on herbal drug extracts (information chapter)(5.23.) ....................................................................................... 807

Monophosphoryl lipid A, 3-O-desacyl-4- .......................... 2207Montelukast sodium........................................................ 9.1-4179Morantel hydrogen tartrate for veterinary use ................... 3090Morphine hydrochloride ....................................................... 3091Morphine sulfate..................................................................... 3093Moss, Iceland........................................................................... 1392Mother tinctures for homoeopathic preparations .............. 1571

Motherwort ............................................................................. 1444Moulds for allergen products ................................................ 3094Mouthwashes.................................................................... 9.3-4788Moxidectin for veterinary use............................................... 3095Moxifloxacin hydrochloride .................................................. 3098Moxonidine ............................................................................. 3100Mucoadhesive preparations............................................ 9.3-4789Mullein flower ......................................................................... 1445Multidose containers, uniformity of mass of delivered doses(2.9.27.) .................................................................................... 347

Mumps, measles and rubella vaccine (live)........................... 952Mumps, measles, rubella and varicella vaccine (live) .......... 953Mumps vaccine (live) ............................................................... 959Mupirocin ................................................................................ 3101Mupirocin calcium ................................................................. 3102Mycobacteria (2.6.2.)................................................................ 188Mycophenolate mofetil .......................................................... 3104Mycophenolate sodium.......................................................... 3105Mycoplasma gallisepticum vaccine (inactivated) ............... 1075Mycoplasmas (2.6.7.)................................................................ 188myo-Inositol ............................................................................ 2761Myrrh ................................................................................ 9.2-4468Myrrh tincture ................................................................. 9.2-4469Myxomatosis vaccine (live) for rabbits ................................ 1076

NNabumetone ............................................................................ 3109N-Acetyltryptophan ............................................................... 1639N-Acetyltyrosine ..................................................................... 1641Nadolol..................................................................................... 3110Nadroparin calcium ............................................................... 3111Naftidrofuryl hydrogen oxalate ............................................ 3113Nalidixic acid .......................................................................... 3115Naloxone hydrochloride dihydrate................................ 9.3-4957Naltrexone hydrochloride...................................................... 3118Names of herbal drugs used in traditional Chinese medicine(5.22.) ..............................................................................9.3-4763

Nandrolone decanoate ........................................................... 3120Naphazoline hydrochloride ................................................... 3122Naphazoline nitrate ................................................................ 3123Naproxen ................................................................................. 3124Naproxen sodium ................................................................... 3126Narrow-leaved coneflower root ............................................ 1447Nasal drops and liquid nasal sprays ....................................... 867Nasal powders ........................................................................... 867Nasal preparations .................................................................... 866Nasal preparations, semi-solid................................................ 868Nasal sprays (liquid) and nasal drops .................................... 866Nasal sticks ................................................................................ 868Nasal washes.............................................................................. 868Nateglinide .............................................................................. 3128Near-infrared spectroscopy (2.2.40.)........................................ 64Nebulisation, characterisation of preparations for(2.9.44.) .................................................................................... 378

Nebulisation, liquid preparations for ..................................... 876Neohesperidin-dihydrochalcone .......................................... 3130Neomycin sulfate .................................................................... 3132Neonatal piglet colibacillosis vaccine (inactivated)............ 1077Neonatal ruminant colibacillosis vaccine (inactivated)..... 1079Neostigmine bromide............................................................. 3134Neostigmine metilsulfate ....................................................... 3135Neroli oil .................................................................................. 1449Netilmicin sulfate............................................................. 9.2-4579Nettle leaf................................................................................. 1450Nettle root................................................................................ 1452Neurovirulence test of live viral vaccines (2.6.18.) ............... 212Nevirapine ........................................................................ 9.3-4959Nevirapine hemihydrate ........................................................ 3139Newcastle disease vaccine (inactivated)............................... 1080Newcastle disease vaccine (live)............................................ 1082Niaouli oil, cineole type ......................................................... 1453Nicardipine hydrochloride ............................................. 9.3-4960

5064 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Nicergoline .............................................................................. 3140Nickel in hydrogenated vegetable oils (2.4.31.) .................... 157Nickel in polyols (2.4.15.) ........................................................ 137Niclosamide............................................................................. 3142Niclosamide monohydrate .................................................... 3143Nicorandil................................................................................ 3144Nicotinamide........................................................................... 3145Nicotine.................................................................................... 3146Nicotine ditartrate dihydrate................................................. 3147Nicotine resinate ..................................................................... 3148Nicotinic acid ................................................................... 9.3-4961Nifedipine ................................................................................ 3151Niflumic acid........................................................................... 3152Nifuroxazide............................................................................ 3154Nikethamide............................................................................ 3155Nilutamide............................................................................... 3156Nimesulide............................................................................... 3157Nimodipine ............................................................................. 3158Nitrazepam.............................................................................. 3159Nitrendipine ............................................................................ 3160Nitric acid ................................................................................ 3161Nitric oxide.............................................................................. 3162Nitrofural ................................................................................. 3163Nitrofurantoin......................................................................... 3164Nitrogen ................................................................................... 3165Nitrogen determination by sulfuric acid digestion (2.5.9.).. 164Nitrogen determination, primary aromatic amino (2.5.8.).. 163Nitrogen, low-oxygen............................................................. 3166Nitrogen monoxide and nitrogen dioxide in gases(2.5.26.) .................................................................................... 170

Nitroprusside, sodium ........................................................... 3593Nitrous oxide........................................................................... 3166Nitrous oxide in gases (2.5.35.)............................................... 176Nizatidine ................................................................................ 3167N-Methylpyrrolidone ............................................................. 3046NMR spectrometry (2.2.33.) ..................................................... 54NMR spectrometry, peptide identification by (2.2.64.)....... 112N,N-Dimethylaniline (2.4.26.) ................................................ 152Nomegestrol acetate ............................................................... 3169Nonoxinol 9............................................................................. 3170Non-sterile pharmaceutical preparations and substances forpharmaceutical use, microbiological quality of (5.1.4.)..... 579

Non-sterile products, microbiological examination of(microbial enumeration tests) (2.6.12.) ............................... 195

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.).................................... 199

Noradrenaline hydrochloride......................................... 9.3-4962Noradrenaline tartrate .................................................... 9.3-4964Norepinephrine hydrochloride ...................................... 9.3-4962Norepinephrine tartrate.................................................. 9.3-4964Norethisterone ........................................................................ 3174Norethisterone acetate ........................................................... 3175Norfloxacin....................................................................... 9.3-4965Norflurane ............................................................................... 3179Norgestimate ........................................................................... 3184Norgestrel ................................................................................ 3185Normal immunoglobulin for intramuscular administration,human .................................................................................... 2685

Normal immunoglobulin for intravenous administration,human .................................................................................... 2687

Normal immunoglobulin for subcutaneous administration,human .................................................................................... 2689

Nortriptyline hydrochloride........................................... 9.3-4967Noscapine ................................................................................ 3187Noscapine hydrochloride hydrate......................................... 3188Notoginseng root .................................................................... 1454Nuclear magnetic resonance spectrometry (2.2.33.).............. 54Nuclear magnetic resonance spectrometry, peptideidentification by (2.2.64.)....................................................... 112

Nucleated cell count and viability (2.7.29.) ........................... 275Nucleic acid amplification techniques (2.6.21.) .................... 214Nucleic acids in polysaccharide vaccines (2.5.17.) ............... 166

Numeration of CD34/CD45+ cells in haematopoietic products(2.7.23.) .................................................................................... 269

Nutmeg oil ............................................................................... 1455Nux-vomica for homoeopathic preparations ............... 9.3-4829Nystatin.................................................................................... 3189

OO-Acetyl in polysaccharide vaccines (2.5.19.)....................... 167Oak bark .................................................................................. 1456Octoxinol 10............................................................................ 3193Octyldodecanol ....................................................................... 3194Octyl gallate............................................................................. 3193Odour (2.3.4.)............................................................................ 127Odour and taste of essential oils (2.8.8.)................................ 284Ofloxacin.................................................................................. 3195Oils, essential............................................................................. 814Oils, fatty, identification by thin-layer chromatography(2.3.2.) ...................................................................................... 126

Oils, fatty, vegetable.................................................................. 848Oils rich in omega-3 acids, composition of fatty acids in(2.4.29.) .................................................................................... 155

Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ..... 157Ointments .................................................................................. 883Olanzapine............................................................................... 3196Oleic acid ................................................................................. 3197Oleoresins .................................................................................. 818Oleoyl macrogolglycerides ............................................. 9.1-4185Oleyl alcohol............................................................................ 3199Olive leaf .................................................................................. 1456Olive leaf dry extract .............................................................. 1458Olive oil, refined .............................................................. 9.3-4973Olive oil, virgin ................................................................ 9.3-4973Olmesartan medoxomil ......................................................... 3201Olsalazine sodium .................................................................. 3203Omega-3-acid ethyl esters 60 ................................................ 3205Omega-3-acid ethyl esters 90 ......................................... 9.2-4583Omega-3 acids, composition of fatty acids in oils rich in(2.4.29.) .................................................................................... 155

Omega-3 acids, fish oil rich in .............................................. 2474Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ..... 157Omega-3-acid triglycerides ................................................... 3209Omeprazole ............................................................................. 3211Omeprazole magnesium........................................................ 3213Omeprazole sodium ............................................................... 3214Ondansetron hydrochloride dihydrate ................................ 3216Opalescence of liquids, clarity and degree of (2.2.1.) ..9.2-4285Ophthalmic inserts ................................................................... 858Opium dry extract, standardised.......................................... 1459Opium, prepared .................................................................... 1460Opium, raw.............................................................................. 1461Opium tincture, standardised ............................................... 1463Optical microscopy (2.9.37.) ................................................... 365Optical rotation (2.2.7.) ............................................................. 26Oral drops.........................................................................9.3-4786Oral lyophilisates ............................................................. 9.3-4792Oral powders............................................................................. 874Oral solutions, emulsions and suspensions.................. 9.3-4786Oral use, liquid preparations for ................................... 9.3-4785Oral use, veterinary semi-solid preparations for .................. 890Orbifloxacin for veterinary use............................................. 3217Orciprenaline sulfate .............................................................. 3219Oregano ................................................................................... 1464Organ preservation, solutions for......................................... 3612Oriental cashew for homoeopathic preparations ............... 1591Orientvine stem ...................................................................... 1466Orodispersible films ........................................................ 9.3-4790Orodispersible tablets ..................................................... 9.3-4792Oromucosal capsules....................................................... 9.3-4789Oromucosal drops, oromucosal sprays and sublingualsprays............................................................................... 9.3-4788

Oromucosal preparations ............................................... 9.3-4787Oromucosal preparations, semi-solid ........................... 9.3-4788

General Notices (1) apply to all monographs and other texts 5065

Index EUROPEAN PHARMACOPOEIA 9.3

Oromucosal solutions and oromucosal suspensions...9.3-4788Oromucosal sprays, oromucosal drops and sublingualsprays............................................................................... 9.3-4787

Oromucosal suspensions and oromucosal solutions...9.3-4787Orphenadrine citrate.............................................................. 3220Orphenadrine hydrochloride ................................................ 3222Oseltamivir phosphate .................................................... 9.2-4585Osmolality (2.2.35.) .................................................................... 59Ouabain ................................................................................... 3225Oxacillin sodium monohydrate ............................................ 3226Oxaliplatin ............................................................................... 3228Oxazepam................................................................................ 3231Oxcarbazepine......................................................................... 3232Oxeladin hydrogen citrate ..................................................... 3234Oxfendazole for veterinary use ............................................. 3235Oxidising substances (2.5.30.)................................................. 171Oxitropium bromide .............................................................. 3236Oxolinic acid ........................................................................... 3237Oxprenolol hydrochloride ..................................................... 3239Oxybuprocaine hydrochloride .............................................. 3239Oxybutynin hydrochloride .................................................... 3241Oxycodone hydrochloride ..................................................... 3242Oxygen ..................................................................................... 3243Oxygen (15O) ........................................................................... 1163Oxygen (93 per cent).............................................................. 3244Oxygen-flask method (2.5.10.)................................................ 164Oxygen in gases (2.5.27.) ......................................................... 170Oxymetazoline hydrochloride............................................... 3245Oxytetracycline dihydrate...................................................... 3247Oxytetracycline hydrochloride.............................................. 3249Oxytocin .................................................................................. 3250Oxytocin concentrated solution............................................ 3251

PPaclitaxel .................................................................................. 3255Pale coneflower root............................................................... 1467Palmitic acid............................................................................ 3259Pamidronate disodium pentahydrate................................... 3259Pancreas powder ..................................................................... 3260Pancuronium bromide ........................................................... 3263Panleucopenia vaccine (inactivated), feline ........................ 1056Panleucopenia vaccine (live), feline ..................................... 1057Pansy, wild (flowering aerial parts)...................................... 1558Pantoprazole sodium sesquihydrate..................................... 3264Pantothenate, calcium............................................................ 1929Papaverine hydrochloride...................................................... 3265Paper chromatography (2.2.26.) ............................................... 42Papillomavirus vaccine (rDNA), human .............................. 936Paraben, butyl ......................................................................... 1892Paraben, ethyl.......................................................................... 2428Paraben, methyl ...................................................................... 3029Paraben, propyl ....................................................................... 3436Paraben, sodium ethyl............................................................ 3577Paraben, sodium methyl ........................................................ 3591Paraben, sodium propyl......................................................... 3599Paracetamol ............................................................................. 3267Paraffin, hard........................................................................... 3268Paraffin, light liquid ............................................................... 3269Paraffin, liquid ........................................................................ 3269Paraffin, white soft.................................................................. 3270Paraffin, yellow soft ................................................................ 3271Parahydroxybenzoate, butyl .................................................. 1892Parahydroxybenzoate, ethyl .................................................. 2428Parahydroxybenzoate, methyl ............................................... 3029Parahydroxybenzoate, propyl................................................ 3436Parahydroxybenzoate, sodium ethyl .................................... 3577Parahydroxybenzoate, sodium methyl................................. 3591Parahydroxybenzoate, sodium propyl.................................. 3599Parainfluenza virus vaccine (live), bovine ........................... 1021Parainfluenza virus vaccine (live), canine ........................... 1032Paraldehyde ............................................................................. 3271

Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ....................................................................................... 1080

Paramyxovirus 1 (Newcastle disease) vaccine (live),avian ....................................................................................... 1082

Paramyxovirus 3 vaccine (inactivated) for turkeys, avian.. 1016Parenteral preparations............................................................ 871Parenteral preparations, test for extractable volume of(2.9.17.) .................................................................................... 322

Parnaparin sodium................................................................. 3272Paroxetine hydrochloride ...................................................... 3272Paroxetine hydrochloride hemihydrate ............................... 3275Particles, fine, aerodynamic assessment of in preparations forinhalation (2.9.18.) ................................................................. 323

Particle size analysis by laser light diffraction (2.9.31.) ....... 349Particle-size distribution estimation by analytical sieving(2.9.38.) .................................................................................... 367

Particulate contamination : sub-visible particles (2.9.19.) ... 335Particulate contamination : visible particles (2.9.20.)........... 337Parvovirosis vaccine (inactivated), canine........................... 1033Parvovirosis vaccine (inactivated), porcine......................... 1089Parvovirosis vaccine (live), canine........................................ 1034Passion flower ......................................................................... 1469Passion flower dry extract ..................................................... 1470Pastes .......................................................................................... 884Pasteurella vaccine (inactivated) for sheep.......................... 1084Pastilles and lozenges ...................................................... 9.3-4789Patches, cutaneous.................................................................... 882Patches, transdermal ................................................................ 873Patches, transdermal, dissolution test for (2.9.4.)................. 309Pea starch................................................................................. 3277Pefloxacin mesilate dihydrate................................................ 3277Pelargonium root .................................................................... 1470Pemetrexed disodium heptahydrate..................................... 3279Penbutolol sulfate ................................................................... 3281Penetrometry, measurement of consistency by (2.9.9.) ....... 313Penicillamine........................................................................... 3282Penicillin G, benzathine......................................................... 1822Penicillin G potassium.................................................... 9.2-4505Penicillin G, procaine...................................................... 9.2-4506Penicillin G sodium......................................................... 9.2-4508Penicillin V....................................................................... 9.1-4189Penicillin V potassium .................................................... 9.1-4190Pentaerythrityl tetranitrate, diluted...................................... 3284Pentamidine diisetionate ....................................................... 3286Pentazocine.............................................................................. 3287Pentazocine hydrochloride .................................................... 3287Pentazocine lactate ................................................................. 3288Pentetate sodium calcium for radiopharmaceuticalpreparations ................................................................... 9.3-4800

Pentobarbital ........................................................................... 3289Pentobarbital sodium ............................................................. 3289Pentoxifylline .......................................................................... 3290Pentoxyverine hydrogen citrate ............................................ 3292Peony root, red........................................................................ 1471Peony root, white .................................................................... 1472Pepper ...................................................................................... 1474Pepper, long............................................................................. 1417Peppermint leaf................................................................ 9.2-4469Peppermint leaf dry extract............................................ 9.2-4471Peppermint oil ........................................................................ 1478Pepsin powder......................................................................... 3293Peptide identification by nuclear magnetic resonancespectrometry (2.2.64.) ............................................................ 112

Peptide mapping (2.2.55.).......................................................... 90Peptides, synthetic, acetic acid in (2.5.34.) ............................ 175Perborate, hydrated sodium .................................................. 3594Pergolide mesilate ................................................................... 3295Perindopril tert-butylamine .................................................. 3296Peritoneal dialysis, solutions for ........................................... 3299Permethrin (25:75) ................................................................. 3301Peroxide value (2.5.5.) .............................................................. 162Perphenazine........................................................................... 3303

5066 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed) ................................................................. 902

Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed, reduced antigen(s) content)................. 903

Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) ............ 908

Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ............................... 910

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed)................... 911

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 913

Pertussis (acellular, component), diphtheria, tetanus,hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ............ 915

Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 917

Pertussis toxin (residual) and pertussis toxoid (irreversibilityof) (2.6.33.).............................................................................. 235

Pertussis vaccine (acellular), assay of (2.7.16.)...................... 263Pertussis vaccine (acellular, component, adsorbed)............. 960Pertussis vaccine (acellular, co-purified, adsorbed) ............. 962Pertussis vaccine (whole cell, adsorbed)................................ 963Pertussis vaccine (whole cell), assay of (2.7.7.) ..................... 252Pertussis (whole cell), diphtheria and tetanus vaccine(adsorbed) ............................................................................... 905

Pertussis (whole cell), diphtheria, tetanus and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 920

Pertussis (whole cell), diphtheria, tetanus, poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 922

Peru balsam ............................................................................. 1479Pessaries ..................................................................................... 888Pessaries and suppositories, disintegration of (2.9.2.) ......... 301Pesticide residues (2.8.13.)....................................................... 286Pethidine hydrochloride ........................................................ 3304Petroleum rectificatum for homoeopathic preparations ... 1612Pharmaceutical preparations.......................................... 9.3-4775Pharmaceutical technical procedures (2.9.) .......................... 299Pharmacognosy, methods in (2.8.)......................................... 283Pharmacopoeial harmonisation (5.8.) .......................... 9.3-4741Phenazone................................................................................ 3305Pheniramine maleate.............................................................. 3306Phenobarbital .......................................................................... 3307Phenobarbital sodium............................................................ 3309Phenol ...................................................................................... 3310Phenol in immunosera and vaccines (2.5.15.) ...................... 166Phenolphthalein...................................................................... 3311Phenolsulfonphthalein ........................................................... 3311Phenothiazines, identification by thin-layer chromatography(2.3.3.) ...................................................................................... 127

Phenoxyethanol ...................................................................... 3312Phenoxymethylpenicillin ................................................ 9.1-4189Phenoxymethylpenicillin potassium ............................. 9.1-4190Phentolamine mesilate ........................................................... 3317Phenylalanine .......................................................................... 3318Phenylbutazone....................................................................... 3319Phenylbutyrate, sodium ......................................................... 3595Phenylephrine ......................................................................... 3321Phenylephrine hydrochloride................................................ 3322Phenylmercuric acetate .......................................................... 3324Phenylmercuric borate........................................................... 3324Phenylmercuric nitrate .......................................................... 3325Phenylpropanolamine hydrochloride .................................. 3325Phenytoin................................................................................. 3326Phenytoin sodium................................................................... 3327Phloroglucinol......................................................................... 3329Phloroglucinol dihydrate ....................................................... 3330pH of solutions, approximate (2.2.4.)....................................... 25Pholcodine monohydrate ............................................... 9.1-4192Phosphates (2.4.11.).................................................................. 136

Phospholipids for injection, egg .................................... 9.2-4533Phosphoric acid, concentrated.............................................. 3333Phosphoric acid, dilute .......................................................... 3334Phosphorus in polysaccharide vaccines (2.5.18.) ................. 166pH, potentiometric determination of (2.2.3.) ......................... 24Phthalylsulfathiazole .............................................................. 3334Physical and physicochemical methods (2.2.) ........................ 21Physostigmine salicylate ........................................................ 3335Phytomenadione ..................................................................... 3336Phytosterol............................................................................... 3337Picosulfate, sodium ................................................................ 3596Picotamide monohydrate....................................................... 3338Picric acid for homoeopathic preparations ......................... 1587Piglet colibacillosis vaccine (inactivated), neonatal ........... 1077Pillules for homoeopathic preparations............................... 1586Pillules, homoeopathic, coated ............................................. 1587Pillules, homoeopathic, impregnated............................ 9.1-4118Pilocarpine hydrochloride ..................................................... 3339Pilocarpine nitrate .................................................................. 3340Pimobendan ............................................................................ 3342Pimozide .................................................................................. 3343Pindolol.................................................................................... 3344Pine (dwarf) oil....................................................................... 1340Pine sylvestris oil .................................................................... 1480Pioglitazone hydrochloride ................................................... 3345Pipemidic acid trihydrate ...................................................... 3346Piperacillin............................................................................... 3347Piperacillin sodium ................................................................ 3349Piperazine adipate .................................................................. 3351Piperazine citrate .................................................................... 3352Piperazine hydrate .................................................................. 3352Piracetam................................................................................. 3353Pirenzepine dihydrochloride monohydrate ........................ 3354Piretanide................................................................................. 3356Pirfenidone .............................................................................. 3357Piroxicam................................................................................. 3358Pivampicillin ........................................................................... 3359Pivmecillinam hydrochloride................................................ 3361Plasma for fractionation, human.......................................... 2691Plasma (pooled and treated for virus inactivation),human ............................................................................. 9.2-4555

Plasmid vectors for human use, bacterial cells used for themanufacture of........................................................................ 741

Plasmin inhibitor, assay of human (2.7.25.).......................... 272Plasters, medicated ................................................................... 882Plastic additives (3.1.13.) ......................................................... 414Plastic containers and closures for pharmaceutical use(3.2.2.) ...................................................................................... 428

Plastic containers for aqueous solutions for infusion(3.2.2.1.) ................................................................................... 429

Plastic containers for human blood and blood components,sterile (3.2.3.)........................................................................... 430

Plastic syringes, single-use, sterile (3.2.8.)............................. 434Pneumococcal polysaccharide conjugate vaccine(adsorbed) ............................................................................... 965

Pneumococcal polysaccharide vaccine .................................. 967Pneumonia vaccine (inactivated), porcine enzootic .......... 1086Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content)............................... 906

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ......................... 911

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reduced antigen(s)content).................................................................................... 913

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(whole cell) vaccine (adsorbed) ............................................ 920

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 917

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) .................................... 915

General Notices (1) apply to all monographs and other texts 5067

Index EUROPEAN PHARMACOPOEIA 9.3

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(whole cell) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 922

Poliomyelitis vaccine (inactivated) ......................................... 969Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) .................................................................................... 267

Poliomyelitis vaccine (oral) ............................................ 9.1-4091Pollens for allergen products................................................. 3362Poloxamers .............................................................................. 3363Polyacrylate dispersion 30 per cent ...................................... 3365Polyamide 6/6 suture, sterile, in distributor for veterinary use................................................................................................ 1221

Polyamide 6 suture, sterile, in distributor for veterinary use................................................................................................ 1220

Polyethyleneglycols................................................................. 2950Polyethyleneglycols, high-molecular-mass.......................... 2952Polyethylene oxides, high-molecular-mass ......................... 2952Polyethylene terephthalate for containers for preparations notfor parenteral use (3.1.15.) .................................................... 419

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use ....................................................................... 1221

Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.).......... 9.2-4318

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations(3.1.5.) ............................................................................. 9.2-4311

Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations(3.1.4.) ............................................................................. 9.2-4310

Polygonum cuspidatum rhizome and root.......................... 1481Polygonum orientale fruit .............................................. 9.2-4472Polymorphism (5.9.)................................................................. 719Polymyxin B sulfate ................................................................ 3366Polyolefins (3.1.3.) ........................................................... 9.2-4307Polyoxyl castor oil................................................................... 2950Polyoxyl hydrogenated castor oil .......................................... 2949Polyoxypropylene stearyl ether ............................................. 3367Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.)... 9.2-4314

Polysaccharide vaccines for human use, conjugated, carrierproteins for the production of (5.2.11.) ............................... 626

Polysaccharide vaccines, hexosamines in (2.5.20.) ............... 167Polysaccharide vaccines, methylpentoses in (2.5.21.) .......... 167Polysaccharide vaccines, nucleic acids in (2.5.17.) ............... 166Polysaccharide vaccines, O-acetyl in (2.5.19.)....................... 167Polysaccharide vaccines, phosphorus in (2.5.18.)................. 166Polysaccharide vaccines, protein in (2.5.16.)......................... 166Polysaccharide vaccines, ribose in (2.5.31.) .......................... 171Polysaccharide vaccines, sialic acid in (2.5.23.) .................... 168Polysaccharide vaccines, uronic acids in (2.5.22.) ................ 168Polysorbate 20 ......................................................................... 3368Polysorbate 40 ......................................................................... 3369Polysorbate 60 ......................................................................... 3370Polysorbate 80 .................................................................. 9.2-4591Polystyrene sulfonate, sodium .............................................. 3597Poly(vinyl acetate) ........................................................... 9.3-4977Poly(vinyl acetate) dispersion 30 per cent .................... 9.3-4978Poly(vinyl alcohol)........................................................... 9.3-4979Poly(vinyl alcohol) macrogol grafted copolymer ............... 2945Poly(vinyl chloride) (non-plasticised) for containers for soliddosage forms for oral administration, materials based on(3.1.11.) .................................................................................... 412

Poly(vinyl chloride), non-plasticised, materials based on forcontainers for non-injectable aqueous solutions (3.1.10.).. 410

Poly(vinyl chloride), plasticised, empty sterile containers offor human blood and blood components (3.2.4.) .............. 432

Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) .................................................................................... 416

Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ................................................................................... 391

Poly(vinyl chloride), plasticised, materials based on fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.)............................................................. 393

Poly(vinyl chloride), plasticised, sterile containers of forhuman blood containing anticoagulant solution (3.2.5.) .. 432

Poppy petals, red..................................................................... 1492Porcine actinobacillosis vaccine (inactivated) .................... 1085Porcine enzootic pneumonia vaccine (inactivated) ........... 1086Porcine influenza vaccine (inactivated) ............................... 1087Porcine insulin ................................................................. 9.3-4931Porcine parvovirosis vaccine (inactivated).......................... 1089Porcine progressive atrophic rhinitis vaccine(inactivated) .......................................................................... 1090

Pore-size distribution of solids by mercury porosimetry,porosity and (2.9.32.) ............................................................. 352

Poria ......................................................................................... 1484Porosimetry, mercury, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 352

Porosity and pore-size distribution of solids by mercuryporosimetry (2.9.32.).............................................................. 352

Porosity of sintered-glass filters (2.1.2.) ................................... 15Porous solids including powders, wettability of (2.9.45.) .... 381Potassium (2.4.12.) ................................................................... 136Potassium acetate.................................................................... 3375Potassium bromide................................................................. 3376Potassium carbonate............................................................... 3377Potassium chloride ................................................................. 3377Potassium citrate..................................................................... 3378Potassium clavulanate ............................................................ 3378Potassium clavulanate, diluted.............................................. 3381Potassium dichromate for homoeopathic preparations..... 1608Potassium dihydrogen phosphate......................................... 3382Potassium disulfite.................................................................. 3386Potassium hydrogen aspartate hemihydrate ....................... 3383Potassium hydrogen carbonate ............................................. 3384Potassium hydrogen tartrate ................................................. 3384Potassium hydroxide .............................................................. 3385Potassium iodide..................................................................... 3385Potassium metabisulfite ......................................................... 3386Potassium nitrate .................................................................... 3386Potassium perchlorate............................................................ 3387Potassium permanganate....................................................... 3388Potassium sodium tartrate tetrahydrate .............................. 3388Potassium sorbate ................................................................... 3389Potassium sulfate .................................................................... 3389Potato starch............................................................................ 3390Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)............................................. 60

Potentiometric determination of pH (2.2.3.) .......................... 24Potentiometric titration (2.2.20.).............................................. 35Potentisation, methods of preparation of homoeopathic stocksand................................................................................... 9.2-4479

Poultices ..................................................................................... 884Pour-on preparations ...................................................... 9.3-4792Povidone ........................................................................... 9.2-4592Povidone, iodinated................................................................ 3394Powdered cellulose ................................................................. 2013Powder fineness (2.9.35.) ......................................................... 362Powder flow (2.9.36.)................................................................ 362Powders and granules for oral solutions andsuspensions..................................................................... 9.3-4786

Powders and granules for syrups ................................... 9.3-4787Powders and tablets for rectal solutions and suspensions... 882Powders, bulk density and tapped density of (2.9.34.)......... 359Powders, ear .............................................................................. 856Powders, effervescent ............................................................... 875Powders for cutaneous application......................................... 874Powders for eye drops and powders for eye lotions ............. 858Powders for injections or infusions........................................ 872Powders for oral drops.................................................... 9.3-4786Powders, inhalation .................................................................. 878Powders, nasal ........................................................................... 867Powders, oral ............................................................................. 874

5068 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Powders, wettability of porous solids including (2.9.45.) .... 381Pramipexole dihydrochloride monohydrate ....................... 3394Pravastatin sodium................................................................. 3396Prazepam ................................................................................. 3397Praziquantel............................................................................. 3398Prazosin hydrochloride.......................................................... 3400Prednicarbate .......................................................................... 3401Prednisolone............................................................................ 3403Prednisolone acetate............................................................... 3404Prednisolone pivalate ............................................................. 3406Prednisolone sodium phosphate........................................... 3407Prednisone........................................................................ 9.3-4980Pregabalin ......................................................................... 9.2-4595Pregelatinised hydroxypropyl starch .................................... 3647Pregelatinised starch............................................................... 3649Prekallikrein activator (2.6.15.)............................................... 208Premixes for medicated feeding stuffs for veterinary use ... 875Preparations for inhalation ..................................................... 875Preparations for inhalation: aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 323

Preparations for irrigation....................................................... 880Preparations for nebulisation : characterisation (2.9.44.) .... 378Pressurised pharmaceutical preparations.............................. 880Prilocaine................................................................................. 3412Prilocaine hydrochloride ....................................................... 3413Primaquine diphosphate........................................................ 3415Primary aromatic amino-nitrogen, determination of(2.5.8.) ...................................................................................... 163

Primary standards for volumetric solutions (4.2.1.) ... 9.2-4324Primidone ......................................................................... 9.3-4982Primula root ............................................................................ 1485Probenecid............................................................................... 3417Procainamide hydrochloride................................................. 3418Procaine benzylpenicillin ............................................... 9.2-4506Procaine hydrochloride.......................................................... 3419Prochlorperazine maleate ...................................................... 3420Products of fermentation......................................................... 830Products of recombinant DNA technology........................... 836Products with risk of transmitting agents of animal spongiformencephalopathies .................................................................... 832

Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) .................................................................... 274

Progesterone............................................................................ 3420Progressive atrophic rhinitis vaccine (inactivated),porcine ................................................................................... 1090

Proguanil hydrochloride................................................. 9.2-4597Proline...................................................................................... 3424Promazine hydrochloride ...................................................... 3425Promethazine hydrochloride................................................. 3426Propacetamol hydrochloride................................................. 3427Propafenone hydrochloride................................................... 3428Propanol................................................................................... 3430Propanol and methanol, 2-, test for (2.9.11.) ........................ 318Propantheline bromide .......................................................... 3431Propofol ................................................................................... 3432Propranolol hydrochloride .................................................... 3434Propylene glycol...................................................................... 3437Propylene glycol dicaprylocaprate........................................ 3438Propylene glycol dilaurate .............................................. 9.2-4598Propylene glycol monolaurate............................................... 3439Propylene glycol monopalmitostearate................................ 3440Propylene glycol monostearate ............................................. 3440Propyl gallate........................................................................... 3435Propyl parahydroxybenzoate................................................. 3436Propyl parahydroxybenzoate, sodium ................................. 3599Propylthiouracil ...................................................................... 3441Propyphenazone ..................................................................... 3442Protamine sulfate .................................................................... 3443Protein assays, host-cell (2.6.34.) ................................... 9.1-4041Protein C, human, assay of (2.7.30.)....................................... 276Protein in polysaccharide vaccines (2.5.16.) ......................... 166Protein S, human, assay of (2.7.31.) ....................................... 277Protein, total (2.5.33.) .............................................................. 172

Prothrombin complex, human.............................................. 2695Protirelin.................................................................................. 3444Proxyphylline .......................................................................... 3445Pseudoephedrine hydrochloride........................................... 3446Psyllium seed........................................................................... 1486Pullulan.................................................................................... 3447Purified water .......................................................................... 3935Purified water, highly............................................................. 3933Purple coneflower herb.......................................................... 1486Purple coneflower root .......................................................... 1488Pycnometric density of solids, gas (2.9.23.) .......................... 339Pygeum africanum bark ........................................................ 1490Pyrantel embonate.................................................................. 3448Pyrazinamide .......................................................................... 3449Pyridostigmine bromide ........................................................ 3450Pyridoxine hydrochloride...................................................... 3451Pyrimethamine ....................................................................... 3453Pyrogens (2.6.8.) ....................................................................... 193Pyrophosphate (sodium) decahydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4439

Pyrrolidone.............................................................................. 3453

QQuality control of vaccines, substitution of in vivo method(s)by in vitro method(s) for the (5.2.14.) ........................ 9.3-4737

Quality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological(5.1.4.) ...................................................................................... 579

Quantified hawthorn leaf and flower liquid extract ........... 1387Quetiapine fumarate .............................................................. 3457Quillaia bark............................................................................ 1491Quinapril hydrochloride........................................................ 3459Quinidine sulfate .................................................................... 3461Quinine hydrochloride .......................................................... 3463Quinine sulfate........................................................................ 3464

RRabbit haemorrhagic disease vaccine (inactivated) ........... 1092Rabeprazole sodium............................................................... 3469Rabeprazole sodium hydrate................................................. 3470Rabies immunoglobulin, human .......................................... 2696Rabies vaccine for human use prepared in cell cultures...... 976Rabies vaccine (inactivated) for veterinary use .................. 1093Rabies vaccine (live, oral) for foxes and raccoon dogs ...... 1096Racecadotril............................................................................. 3472Racementhol............................................................................ 2998Racemic camphor ................................................................... 1934Racemic ephedrine hydrochloride ....................................... 2363Racemic menthol .................................................................... 2998Racephedrine hydrochloride................................................. 2363Raclopride ([11C]methoxy) injection.................................... 1165Radioactivity, detection and measurement of (2.2.66.) ....... 113Radionuclides, table of physical characteristics (5.7.) .. 9.2-4385Radiopharmaceutical preparations ........................................ 832Radiopharmaceutical preparations, chemical precursorsfor ............................................................................................. 813

Radiopharmaceutical preparations, copper tetramibitetrafluoroborate for...................................................... 9.2-4435

Radiopharmaceutical preparations, iobenguane sulfatefor .................................................................................... 9.2-4435

Radiopharmaceutical preparations, medronic acidfor .................................................................................... 9.2-4437

Radiopharmaceutical preparations, pentetate sodium calciumfor .................................................................................... 9.3-4800

Radiopharmaceutical preparations, sodium iodohippuratedihydrate for................................................................... 9.2-4438

Radiopharmaceutical preparations, sodium pyrophosphatedecahydrate for .............................................................. 9.2-4439

Radiopharmaceutical preparations, tetra-O-acetyl-mannosetriflate for ....................................................................... 9.2-4443

Radiopharmaceuticals, extemporaneous preparation of(5.19.) ....................................................................................... 767

General Notices (1) apply to all monographs and other texts 5069

Index EUROPEAN PHARMACOPOEIA 9.3

Raloxifene hydrochloride ...................................................... 3473Raman spectroscopy (2.2.48.) ................................................... 86Ramipril ................................................................................... 3475Ramon assay, flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (2.7.27.) ................................................... 273

Ranitidine hydrochloride................................................ 9.2-4603Rapeseed oil, refined .............................................................. 3479Raw materials of biological origin for the production ofcell-based and gene therapymedicinal products (5.2.12.).. 627

Reagents (4.) .............................................................................. 441Reagents (4.1.1.)........................................................................ 441Reagents (4.1.1.)............................................................... 9.1-4061Reagents (4.1.1.)............................................................... 9.2-4323Reagents (4.1.1.)............................................................... 9.3-4729Reagents, standard solutions, buffer solutions (4.1.) ........... 441Recombinant DNA technology, products of......................... 836Recommendations on dissolution testing (5.17.1.) .............. 761Recommendations on methods for dosage forms testing(5.17.) ....................................................................................... 761

Rectal capsules .......................................................................... 882Rectal foams .............................................................................. 882Rectal preparations................................................................... 881Rectal preparations, semi-solid............................................... 882Rectal solutions and suspensions, powders and tablets for.. 881Rectal solutions, emulsions and suspensions........................ 882Rectal tampons.......................................................................... 882Red peony root........................................................................ 1471Red poppy petals..................................................................... 1492Reference standards (5.12.) ..................................................... 733Refractive index (2.2.6.) ............................................................. 26Relative density (2.2.5.) .............................................................. 25Remifentanil hydrochloride ........................................... 9.2-4604Repaglinide.............................................................................. 3479Reserpine ................................................................................. 3481Residual pertussis toxin and irreversibility of pertussis toxoid(2.6.33.) .................................................................................... 235

Residual solvents (5.4.) ............................................................ 665Residual solvents, identification and control (2.4.24.) ......... 146Residue on evaporation of essential oils (2.8.9.)................... 284Resistance to crushing of tablets (2.9.8.) ............................... 313Resorcinol ................................................................................ 3481Respiratory syncytial virus vaccine (live), bovine .............. 1022Restharrow root ...................................................................... 1493Retroviridae-derived vectors for human use......................... 746Rhatany root............................................................................ 1494Rhatany tincture ..................................................................... 1495Rhinotracheitis vaccine (inactivated), bovine, infectious.. 1067Rhinotracheitis vaccine (inactivated), viral, feline ............. 1059Rhinotracheitis vaccine (live), bovine, infectious............... 1068Rhinotracheitis vaccine (live), infectious, turkey ............... 1107Rhinotracheitis vaccine (live), viral, feline .......................... 1060Rhubarb ................................................................................... 1496Ribavirin .................................................................................. 3482Riboflavin................................................................................. 3484Riboflavin sodium phosphate ............................................... 3485Ribose in polysaccharide vaccines (2.5.31.) .......................... 171Ribwort plantain ..................................................................... 1497Rice starch ............................................................................... 3487Rifabutin .................................................................................. 3488Rifampicin ............................................................................... 3489Rifamycin sodium................................................................... 3490Rifaximin ................................................................................. 3492Rilmenidine dihydrogen phosphate ..................................... 3494Risedronate sodium 2.5-hydrate........................................... 3495Risperidone ............................................................................. 3496Ritonavir .................................................................................. 3498Rivastigmine............................................................................ 3501Rivastigmine hydrogen tartrate ............................................ 3503Rizatriptan benzoate .............................................................. 3504Rocuronium bromide............................................................. 3506Rolling ball (automatic) and falling ball viscometer methods(2.2.49.) ........................................................................... 9.3-4690

Roman chamomile flower...................................................... 1313

Ropinirole hydrochloride ...................................................... 3508Ropivacaine hydrochloride monohydrate ........................... 3509Roselle ...................................................................................... 1498Rosemary leaf.......................................................................... 1499Rosemary oil ........................................................................... 1500Rosuvastatin calcium.............................................................. 3511Rotating viscometer method - viscosity (2.2.10.) ................... 28Rotation, optical (2.2.7.) ............................................................ 26Rotavirus diarrhoea vaccine (inactivated), calf .................. 1026Rotavirus vaccine (live, oral)................................................... 978Round amomum fruit ............................................................ 1502Roxithromycin ........................................................................ 3513RRR-α-Tocopherol.................................................................. 3801RRR-α-Tocopheryl acetate..................................................... 3804RRR-α-Tocopheryl hydrogen succinate ............................... 3808Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) ...................................................................................... 435

Rubella immunoglobulin, human ........................................ 2698Rubella, measles and mumps vaccine (live) .......................... 952Rubella, measles, mumps and varicella vaccine (live).......... 953Rubella vaccine (live) ............................................................... 981Ruminant colibacillosis vaccine (inactivated), neonatal.... 1079Rupatadine fumarate ....................................................... 9.3-4987Rutoside trihydrate ................................................................. 3516

SSaccharin.................................................................................. 3521Saccharin sodium ................................................................... 3522Safety, viral (5.1.7.) ................................................................... 591Safflower flower ...................................................................... 1503Safflower oil, refined............................................................... 3523Saffron for homoeopathic preparations............................... 1599Sage leaf (Salvia officinalis) ................................................... 1505Sage leaf, three-lobed ............................................................. 1506Sage oil, Spanish...................................................................... 1524Sage tincture ............................................................................ 1507Salbutamol ............................................................................... 3523Salbutamol sulfate................................................................... 3526Salicylic acid ............................................................................ 3528Salmeterol xinafoate ............................................................... 3529Salmonella Enteritidis vaccine (inactivated) for chickens.. 1097Salmonella Enteritidis vaccine (live, oral) for chickens ..... 1098Salmonella Typhimurium vaccine (inactivated) forchickens ................................................................................. 1100

Salmonella Typhimurium vaccine (live, oral) forchickens ................................................................................. 1101

Salmon oil, farmed ................................................................. 3531Salvia miltiorrhiza root and rhizome............................ 9.1-4108Sanguisorba root..................................................................... 1509Saponification value (2.5.6.) .................................................... 163Saquinavir mesilate................................................................. 3533Saw palmetto extract .............................................................. 1509Saw palmetto fruit .................................................................. 1512Schisandra fruit................................................................ 9.1-4110Scopolamine ............................................................................ 2733Scopolamine butylbromide ................................................... 2734Scopolamine hydrobromide .................................................. 2735Selamectin for veterinary use................................................ 3535Selegiline hydrochloride ........................................................ 3537Selenium disulfide .................................................................. 3538Selenium for homoeopathic preparations .................... 9.2-4494Selfheal fruit-spike, common ................................................ 1327Semi-micro determination of water (2.5.12.)........................ 165Semi-solid ear preparations..................................................... 856Semi-solid eye preparations .................................................... 858Semi-solid intrauterine preparations ..................................... 862Semi-solid nasal preparations ................................................. 868Semi-solid oromucosal preparations............................. 9.3-4788Semi-solid preparations for cutaneous application.............. 882Semi-solid preparations for oral use, veterinary .................. 890Semi-solid rectal preparations ................................................ 882

5070 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Semi-solid vaginal preparations ............................................. 889Senega root .............................................................................. 1515Senna leaf................................................................................. 1516Senna leaf dry extract, standardised .................................... 1517Senna pods, Alexandrian....................................................... 1518Senna pods, Tinnevelly .......................................................... 1519Separation techniques, chromatographic (2.2.46.) ......9.2-4286Serine........................................................................................ 3539Sertaconazole nitrate .............................................................. 3540Sertraline hydrochloride........................................................ 3541Sesame oil, refined........................................................... 9.1-4197Sets for the transfusion of blood and blood components(3.2.6.) ...................................................................................... 433

Sevoflurane .............................................................................. 3545Shampoos .................................................................................. 864Shellac ..................................................................................... 3547Shingles (herpes zoster) vaccine (live) ................................... 982Sialic acid in polysaccharide vaccines (2.5.23.)..................... 168Siam benzoin........................................................................... 1272Siam benzoin tincture ............................................................ 1274Sieves (2.1.4.)............................................................................... 16Sieve test (2.9.12.) ..................................................................... 319Sieving, analytical, particle-size distribution estimation by(2.9.38.) .................................................................................... 367

SI (International System) units (1.) ............................... 9.2-4275Sildenafil citrate ............................................................... 9.2-4611Silica, colloidal anhydrous..................................................... 3549Silica, colloidal hydrated........................................................ 3550Silica, dental type.................................................................... 3550Silica, hydrophobic colloidal ................................................. 3551Silicate, aluminium magnesium..................................... 9.3-4839Silicate, aluminium sodium................................................... 1686Silicone elastomer for closures and tubing (3.1.9.)............... 409Silicone oil used as a lubricant (3.1.8.)................................... 408Silk suture, sterile, braided, in distributor for veterinary use................................................................................................ 1221

Silver, colloidal, for external use........................................... 3552Silver nitrate ............................................................................ 3552Simeticone ............................................................................... 3553Simvastatin .............................................................................. 3554Single-dose preparations, uniformity of content (2.9.6.)..... 312Single-dose preparations, uniformity of mass (2.9.5.) ......... 311Sintered-glass filters (2.1.2.) ...................................................... 15Sitagliptin phosphate monohydrate .............................. 9.1-4198Sitagliptin tablets .................................................................... 3557Size-exclusion chromatography (2.2.30.)................................. 47(S)-Lactic acid ......................................................................... 2861Smallpox vaccine (live) ............................................................ 983Sodium acetate ([1-11C]) injection........................................ 1166Sodium acetate trihydrate...................................................... 3558Sodium alendronate trihydrate ............................................. 3559Sodium alginate ...................................................................... 3560Sodium aluminium silicate.................................................... 1686Sodium amidotrizoate............................................................ 3561Sodium aminosalicylate dihydrate ....................................... 3562Sodium ascorbate ................................................................... 3563Sodium aurothiomalate ......................................................... 3565Sodium benzoate .................................................................... 3566Sodium bromide ..................................................................... 3567Sodium calcium edetate......................................................... 3568Sodium calcium pentetate for radiopharmaceuticalpreparations ................................................................... 9.3-4800

Sodium caprylate .................................................................... 3569Sodium carbonate................................................................... 3570Sodium carbonate decahydrate............................................. 3570Sodium carbonate monohydrate .......................................... 3571Sodium carboxymethylcellulose ........................................... 1958Sodium carboxymethylcellulose, cross-linked.................... 2174Sodium carboxymethylcellulose, low-substituted .............. 1958Sodium cetostearyl sulfate..................................................... 3571Sodium chloride...................................................................... 3573Sodium chromate (51Cr) sterile solution.............................. 1167Sodium citrate ......................................................................... 3574

Sodium cromoglicate ............................................................. 3574Sodium cyclamate................................................................... 3576Sodium dihydrogen phosphate dihydrate ........................... 3577Sodium disulfite ...................................................................... 3591Sodium ethyl parahydroxybenzoate..................................... 3577Sodium fluoride ...................................................................... 3579Sodium fluoride (18F) injection............................................. 1168Sodium fusidate ...................................................................... 3579Sodium glycerophosphate, hydrated .................................... 3582Sodium hyaluronate ............................................................... 3583Sodium hydrogen carbonate ................................................. 3585Sodium hydroxide .................................................................. 3585Sodium iodide......................................................................... 3586Sodium iodide (123I) injection ............................................... 1169Sodium iodide (123I) solution for radiolabelling ................. 1170Sodium iodide (131I) capsules for diagnostic use ................ 1170Sodium iodide (131I) capsules for therapeutic use .............. 1171Sodium iodide (131I) solution ................................................ 1172Sodium iodide (131I) solution for radiolabelling ................. 1173Sodium iodohippurate (123I) injection ................................. 1175Sodium iodohippurate (131I) injection ................................. 1176Sodium iodohippurate dihydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4438

Sodium lactate solution ......................................................... 3586Sodium laurilsulfate ........................................................ 9.1-4200Sodium lauroylsarcosinate for external use......................... 3589Sodium metabisulfite ............................................................. 3591Sodium methyl parahydroxybenzoate ................................. 3591Sodium molybdate (99Mo) solution (fission) ...................... 1176Sodium molybdate dihydrate ................................................ 3592Sodium nitrite ......................................................................... 3593Sodium nitroprusside............................................................. 3593Sodium perborate, hydrated.................................................. 3594Sodium pertechnetate (99mTc) injection (accelerator-produced) ....................................................................... 9.3-4801

Sodium pertechnetate (99mTc) injection (fission) ............... 1178Sodium pertechnetate (99mTc) injection (non-fission) ....... 1180Sodium phenylbutyrate.......................................................... 3595Sodium phosphate (32P) injection......................................... 1180Sodium picosulfate ................................................................. 3596Sodium polystyrene sulfonate ............................................... 3597Sodium propionate ................................................................. 3598Sodium propyl parahydroxybenzoate .................................. 3599Sodium pyrophosphate decahydrate for radiopharmaceuticalpreparations ................................................................... 9.2-4439

Sodium risedronate 2.5-hydrate ........................................... 3495Sodium salicylate .................................................................... 3601Sodium selenite....................................................................... 3601Sodium selenite pentahydrate ............................................... 3602Sodium (S)-lactate solution................................................... 3587Sodium starch glycolate (type A)................................... 9.1-4200Sodium starch glycolate (type B) ................................... 9.1-4202Sodium starch glycolate (type C).......................................... 3604Sodium stearate....................................................................... 3605Sodium stearyl fumarate........................................................ 3606Sodium sulfate, anhydrous .................................................... 3607Sodium sulfate decahydrate................................................... 3607Sodium sulfite ......................................................................... 3608Sodium sulfite heptahydrate.................................................. 3608Sodium tetrachloroaurate dihydrate for homoeopathicpreparations .......................................................................... 1593

Sodium thiosulfate.................................................................. 3609Sodium valproate.................................................................... 3609Soft capsules ..................................................................... 9.3-4783Softening time determination of lipophilic suppositories(2.9.22.) .................................................................................... 338

Soft extracts ............................................................................... 817Solid dosage forms, dissolution test for (2.9.3.).................... 302Solid dosage forms, recommendations on dissolution testingof (5.17.1.)................................................................................ 761

Solids by mercury porosimetry, porosity and pore-sizedistribution of (2.9.32.) .......................................................... 352

Solids, density of (2.2.42.).......................................................... 70

General Notices (1) apply to all monographs and other texts 5071

Index EUROPEAN PHARMACOPOEIA 9.3

Solids, gas pycnometric density of (2.9.23.) .......................... 339Solids (porous) including powders, wettability of (2.9.45.).. 381Solifenacin succinate ....................................................... 9.3-4991Solubility in alcohol of essential oils (2.8.10.) ....................... 284Soluble tablets .................................................................. 9.3-4792Solution calorimetry and microcalorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 109

Solutions, emulsions and suspensions, oral ................. 9.3-4786Solutions for haemodialysis................................................... 2628Solutions for haemodialysis, concentrated, water fordiluting................................................................................... 2627

Solutions for haemofiltration and haemodiafiltration ....... 2631Solutions for organ preservation .......................................... 3612Solutions for peritoneal dialysis............................................ 3299Solutions, suspensions, intrauterine....................................... 862Solvents, residual (5.4.) ............................................................ 665Solvents, residual, identification and control (2.4.24.)......... 146Somatostatin............................................................................ 3613Somatropin .............................................................................. 3614Somatropin concentrated solution ....................................... 3616Somatropin for injection ....................................................... 3618Somatropin solution for injection ........................................ 3620Sophora flower ........................................................................ 1520Sophora flower-bud................................................................ 1522Sorbic acid ............................................................................... 3622Sorbitan laurate................................................................ 9.1-4203Sorbitan oleate.................................................................. 9.1-4203Sorbitan palmitate ........................................................... 9.1-4204Sorbitan sesquioleate....................................................... 9.1-4205Sorbitan stearate .............................................................. 9.1-4205Sorbitan trioleate ............................................................. 9.1-4206Sorbitol..................................................................................... 3625Sorbitol, liquid (crystallising) ............................................... 3626Sorbitol, liquid (non-crystallising) ....................................... 3627Sorbitol, liquid, partially dehydrated ................................... 3628Sotalol hydrochloride............................................................. 3629Soya-bean oil, hydrogenated ................................................. 3630Soya-bean oil, refined...................................................... 9.3-4992Spanish sage oil ....................................................................... 1524Specific surface area by air permeability (2.9.14.) ....... 9.1-4053Specific surface area by gas adsorption (2.9.26.) .................. 344Spectinomycin dihydrochloride pentahydrate.................... 3631Spectinomycin sulfate tetrahydrate for veterinary use ...... 3633Spectrometry, atomic absorption (2.2.23.) .............................. 37Spectrometry, atomic emission (2.2.22.) ................................. 36Spectrometry, mass (2.2.43.) ..................................................... 71Spectrometry, nuclear magnetic resonance (2.2.33.) ............. 54Spectrometry, X-ray fluorescence (2.2.37.) .................. 9.3-4689Spectrophotometry, infrared absorption (2.2.24.) ................. 39Spectrophotometry, ultraviolet and visible absorption(2.2.25.) ...................................................................................... 41

Spectroscopy, near-infrared (2.2.40.) ....................................... 64Spectroscopy, Raman (2.2.48.).................................................. 86SPF chicken flocks for the production and quality control ofvaccines (5.2.2.)....................................................................... 599

Spheroids and granules, friability of (2.9.41.) ....................... 375Spike lavender oil.................................................................... 1525Spiramycin........................................................................ 9.2-4612Spirapril hydrochloride monohydrate ................................. 3638Spironolactone ........................................................................ 3639Spot-on preparations....................................................... 9.3-4793Sprays (liquid nasal) and drops (nasal).................................. 867Sprays, veterinary ............................................................ 9.3-4793Squalane................................................................................... 3641Standard solutions for limit tests (4.1.2.)............................... 555Standard solutions for limit tests (4.1.2.)...................... 9.2-4324Standard solutions for limit tests (4.1.2.)...................... 9.3-4730Standards, reference (5.12.) ..................................................... 733Stannous chloride dihydrate.................................................. 3644Stanozolol ................................................................................ 3644Staphysagria for homoeopathic preparations ..................... 1612Star anise.................................................................................. 1529Star anise oil ............................................................................ 1530

Starches, hydroxyethyl ........................................................... 3649Starch glycolate (type A), sodium.................................. 9.1-4200Starch glycolate (type B), sodium.................................. 9.1-4202Starch glycolate (type C), sodium......................................... 3604Starch, hydroxypropyl ............................................................ 3645Starch, hydroxypropyl, pregelatinised.................................. 3647Starch, maize ........................................................................... 2969Starch, pea ............................................................................... 3277Starch, potato .......................................................................... 3390Starch, pregelatinised ............................................................. 3649Starch, rice ............................................................................... 3487Starch, wheat ........................................................................... 3937Starflower (borage) oil, refined ............................................. 1858Statistical analysis of results of biological assays and tests(5.3.) ................................................................................ 9.2-4353

Stavudine ................................................................................. 3653Steam sterilisation of aqueous preparations, application of theF0 concept (5.1.5.) ................................................................... 580

Stearic acid............................................................................... 3655Stearoyl macrogolglycerides ........................................... 9.1-4206Stearyl alcohol ......................................................................... 3657Stem cells, human haematopoietic ....................................... 2682Stephania root, fourstamen ................................................... 1357Sterile braided silk suture in distributor for veterinaryuse........................................................................................... 1221

Sterile catgut ............................................................................ 1207Sterile catgut in distributor for veterinary use.................... 1219Sterile containers of plasticised poly(vinyl chloride) for humanblood containing anticoagulant solution (3.2.5.) ............... 432

Sterile linen thread in distributor for veterinary use ......... 1220Sterile non-absorbable strands in distributor for veterinaryuse........................................................................................... 1222

Sterile non-absorbable sutures .............................................. 1208Sterile plastic containers for human blood and bloodcomponents (3.2.3.)................................................................ 430

Sterile polyamide 6/6 suture in distributor for veterinaryuse........................................................................................... 1221

Sterile polyamide 6 suture in distributor for veterinaryuse........................................................................................... 1220

Sterile poly(ethylene terephthalate) suture in distributor forveterinary use........................................................................ 1221

Sterile products, biological indicators and related microbialpreparations used in the manufacture of (5.1.2.) ...... 9.2-4336

Sterile products, methods of preparation of (5.1.1.) ... 9.2-4333Sterile single-use plastic syringes (3.2.8.) .............................. 434Sterile synthetic absorbable braided sutures ....................... 1212Sterile synthetic absorbable monofilament sutures ............ 1213Sterility (2.6.1.).......................................................................... 185Sterility, guidelines for using the test for (5.1.9.).................. 592Sterols in fatty oils (2.4.23.) ..................................................... 144Sticks .......................................................................................... 884Sticks, intrauterine.................................................................... 862Sticks, nasal ............................................................................... 868St. John’s wort.......................................................................... 1526St. John’s wort dry extract, quantified.................................. 1527Stomata and stomatal index (2.8.3.) ....................................... 283Stramonium leaf .............................................................. 9.2-4473Stramonium, prepared .................................................... 9.2-4475Strands, sterile non-absorbable, in distributor for veterinaryuse .......................................................................................... 1222

Streptokinase concentrated solution .................................... 3658Streptomycin sulfate ............................................................... 3660Strontium (89Sr) chloride injection....................................... 1181Strychnos ignatii for homoeopathic preparations ....... 9.3-4827Subdivision of tablets ...................................................... 9.3-4790Sublingual sprays, oromucosal drops and oromucosalsprays............................................................................... 9.3-4787

Sublingual tablets and buccal tablets............................. 9.3-4789Substances for pharmaceutical use................................ 9.3-4777Substances for pharmaceutical use, control of impurities in(5.10.) ....................................................................................... 723

Substances of animal origin for the production ofimmunological veterinary medicinal products (5.2.5.) ..... 608

5072 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Substitution of in vivo method(s) by in vitro method(s) for thequality control of vaccines (5.2.14.) ............................ 9.3-4737

Sub-visible particles, particulate contamination (2.9.19.) ... 335Sucralfate ................................................................................. 3661Sucralose ...........................................................................9.2-4615Sucrose ..................................................................................... 3664Sucrose monopalmitate.......................................................... 3665Sucrose stearate....................................................................... 3666Sufentanil ................................................................................. 3668Sufentanil citrate ..................................................................... 3669Sugars, lead in (2.4.10.) ............................................................ 136Sugar spheres........................................................................... 3670Sulbactam sodium .................................................................. 3671Sulfacetamide sodium............................................................ 3673Sulfadiazine ............................................................................. 3674Sulfadimethoxine.................................................................... 3676Sulfadimethoxine sodium for veterinary use ...................... 3677Sulfadimidine .......................................................................... 3678Sulfadoxine .............................................................................. 3680Sulfafurazole............................................................................ 3681Sulfaguanidine ........................................................................ 3681Sulfamerazine.......................................................................... 3682Sulfamethizole......................................................................... 3683Sulfamethoxazole.................................................................... 3684Sulfamethoxypyridazine for veterinary use......................... 3685Sulfanilamide........................................................................... 3686Sulfasalazine ..................................................................... 9.2-4617Sulfated ash (2.4.14.) ................................................................ 136Sulfates (2.4.13.) ........................................................................ 136Sulfathiazole ............................................................................ 3689Sulfinpyrazone......................................................................... 3689Sulfur dioxide (2.5.29.)............................................................. 171Sulfur for external use............................................................ 3691Sulfur for homoeopathic preparations................................. 1614Sulfuric acid............................................................................. 3691Sulindac.................................................................................... 3692Sulpiride................................................................................... 3693Sultamicillin ............................................................................ 3694Sultamicillin tosilate dihydrate ............................................. 3697Sumatra benzoin..................................................................... 1273Sumatra benzoin tincture ...................................................... 1274Sumatriptan succinate............................................................ 3699Sunflower oil, refined ............................................................. 3701Supercritical fluid chromatography (2.2.45.) .......................... 74Suppositories ............................................................................. 881Suppositories and pessaries, disintegration of (2.9.2.) ......... 301Suppositories, lipophilic, softening time determination(2.9.22.) .................................................................................... 338

Suspensions, solutions and emulsions, oral ................. 9.3-4786Suspensions, solutions, intrauterine....................................... 862Sutures, sterile non-absorbable ............................................. 1208Sutures, sterile synthetic absorbable braided ..................... 1212Sutures, sterile synthetic absorbable monofilament .......... 1213Suxamethonium chloride ...................................................... 3701Suxibuzone .............................................................................. 3702Sweet fennel............................................................................. 1353Sweet orange oil ...................................................................... 1535Swelling index (2.8.4.) .............................................................. 284Swine erysipelas vaccine (inactivated) ................................. 1104Swine-fever vaccine (live, prepared in cell cultures),classical .................................................................................. 1104

Symbols and abbreviations (1.) ...................................... 9.2-4275Synthetic absorbable braided sutures, sterile ...................... 1212Synthetic absorbable monofilament sutures, sterile ........... 1213Syringes, plastic, sterile single-use (3.2.8.) ............................ 434Syrups................................................................................ 9.3-4787

TTable of physical characteristics of radionuclides mentioned inthe European Pharmacopoeia (5.7.)............................ 9.2-4385

Tablets ............................................................................... 9.3-4790Tablets and capsules, disintegration of (2.9.1.) ..................... 299

Tablets and powders for rectal solutions and suspensions .. 882Tablets, buccal .................................................................. 9.3-4789Tablets, chewable ............................................................. 9.3-4792Tablets, coated.................................................................. 9.3-4791Tablets, dispersible........................................................... 9.3-4792Tablets, effervescent......................................................... 9.3-4791Tablets for intrauterine solutions and suspensions .............. 862Tablets for use in the mouth.................................................... 887Tablets for vaginal solutions and suspensions ...................... 889Tablets, gastro-resistant................................................... 9.3-4791Tablets, intrauterine.................................................................. 862Tablets, modified-release ................................................ 9.3-4791Tablets, orodispersible..................................................... 9.3-4792Tablets, resistance to crushing (2.9.8.) ................................... 313Tablets, soluble ................................................................. 9.3-4792Tablets, subdivision of..................................................... 9.3-4790Tablets, sublingual ........................................................... 9.3-4789Tablets, uncoated ............................................................. 9.3-4791Tablets, uncoated, friability of (2.9.7.) ................................... 312Tablets, vaginal.......................................................................... 888Tacalcitol monohydrate.......................................................... 3707Tacrolimus monohydrate................................................ 9.3-4997Tadalafil.................................................................................... 3708Talc ........................................................................................... 3710Tamoxifen citrate .................................................................... 3712Tampons, ear ............................................................................. 856Tampons, medicated ............................................................... 887Tampons, rectal......................................................................... 882Tampons, vaginal, medicated.................................................. 889Tamsulosin hydrochloride..................................................... 3714Tannic acid .............................................................................. 3716Tannins in herbal drugs (2.8.14.)............................................ 288Tapped density and bulk density of powders (2.9.34.)......... 359Tartaric acid............................................................................. 3716Teat dips ............................................................................ 9.3-4793Tea tree oil ............................................................................... 1536Teat sprays ........................................................................ 9.3-4793Technetium (99mTc) bicisate injection ........................... 9.2-4440Technetium (99mTc) colloidal rhenium sulfide injection ... 1183Technetium (99mTc) colloidal sulfur injection ..................... 1184Technetium (99mTc) colloidal tin injection .......................... 1185Technetium (99mTc) etifenin injection.................................. 1185Technetium (99mTc) exametazime injection ........................ 1187Technetium (99mTc) gluconate injection .............................. 1188Technetium (99mTc) human albumin injection ................... 1189Technetium (99mTc) macrosalb injection ............................. 1190Technetium (99mTc) mebrofenin injection .................... 9.2-4440Technetium (99mTc) medronate injection ............................ 1192Technetium (99mTc) mertiatide injection ............................. 1193Technetium (99mTc) microspheres injection ........................ 1194Technetium (99mTc) oxidronate injection ............................ 1195Technetium (99mTc) pentetate injection ............................... 1196Technetium (99mTc) sestamibi injection........................ 9.2-4441Technetium (99mTc) succimer injection................................ 1199Technetium (99mTc) tin pyrophosphate injection ............... 1199Teicoplanin .............................................................................. 3717Telmisartan.............................................................................. 3718Temazepam.............................................................................. 3720Temozolomide......................................................................... 3722Tenosynovitis vaccine (live), viral, avian ............................. 1017Tenoxicam ............................................................................... 3723Terazosin hydrochloride dihydrate ...................................... 3724Terbinafine hydrochloride ..................................................... 3727Terbutaline sulfate .................................................................. 3728Terconazole.............................................................................. 3729Terfenadine.............................................................................. 3730Teriparatide ............................................................................. 3732Terlipressin ....................................................................... 9.2-4623Terminology used in monographs on biological products(5.2.1.) ...................................................................................... 599

Test for anticomplementary activity of immunoglobulin(2.6.17.) ........................................................................... 9.3-4713

General Notices (1) apply to all monographs and other texts 5073

Index EUROPEAN PHARMACOPOEIA 9.3

Test for anti-D antibodies in human immunoglobulin(2.6.26.) .................................................................................... 225

Test for aristolochic acids in herbal drugs (2.8.21) .............. 292Test for extractable volume of parenteral preparations(2.9.17.) .................................................................................... 322

Test for Fc function of immunoglobulin (2.7.9.) ......... 9.3-4724Test for methanol and 2-propanol (2.9.11.) .......................... 318Test for neurovirulence of live virus vaccines (2.6.18.)........ 212Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) ................... 199

Testosterone............................................................................. 3734Testosterone decanoate .......................................................... 3736Testosterone enantate ............................................................. 3738Testosterone isocaproate ........................................................ 3740Testosterone propionate......................................................... 3741Tests for extraneous agents in viral vaccines for human use(2.6.16.) ........................................................................... 9.3-4711

Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 273

Tetanus and diphtheria vaccine (adsorbed) .......................... 899Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s)content).................................................................................... 900

Tetanus antitoxin for human use .......................................... 1119Tetanus antitoxin for veterinary use..................................... 1123Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 901

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed) ................................................................. 902

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed, reduced antigen(s) content)................. 903

Tetanus, diphtheria and pertussis (whole cell) vaccine(adsorbed) ............................................................................... 905

Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)............................... 906

Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ............ 908

Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 910

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)................... 911

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 913

Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ............ 915

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 917

Tetanus, diphtheria, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 920

Tetanus, diphtheria, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 922

Tetanus immunoglobulin, human ........................................ 2698Tetanus vaccine (adsorbed) ..................................................... 987Tetanus vaccine (adsorbed), assay of (2.7.8.) ........................ 253Tetanus vaccine for veterinary use ....................................... 1106Tetracaine hydrochloride....................................................... 3742Tetracosactide.......................................................................... 3743Tetracycline ............................................................................. 3744Tetracycline hydrochloride.................................................... 3746Tetra-O-acetyl-mannose triflate for radiopharmaceuticalpreparations ................................................................... 9.2-4443

Tetrazepam .............................................................................. 3747Tetryzoline hydrochloride ..................................................... 3749Thallous (201Tl) chloride injection ........................................ 1202Theobromine........................................................................... 3749Theophylline ........................................................................... 3750Theophylline-ethylenediamine ............................................. 3752Theophylline-ethylenediamine hydrate ............................... 3754Theophylline monohydrate ................................................... 3751Thermal analysis (2.2.34.).......................................................... 57

Thermogravimetry (2.2.34.) ...................................................... 57Thiamazole .............................................................................. 3755Thiamine hydrochloride ........................................................ 3756Thiamine nitrate ..................................................................... 3758Thiamphenicol ........................................................................ 3760Thin-layer chromatography (2.2.27.) ....................................... 43Thiocolchicoside crystallised from ethanol ................. 9.3-4999Thiocolchicoside hydrate................................................ 9.3-5002Thioctic acid............................................................................ 3765Thiomersal............................................................................... 3766Thiopental sodium and sodium carbonate ......................... 3767Thioridazine ............................................................................ 3768Thioridazine hydrochloride .................................................. 3770Thomson kudzuvine root ............................................... 9.3-4820Three-lobed sage leaf ............................................................. 1506Threonine ................................................................................ 3771Thyme ...................................................................................... 1538Thyme oil, thymol type.......................................................... 1540Thyme, wild............................................................................. 1559Thymol..................................................................................... 3772Thymol type thyme oil........................................................... 1540Tiabendazole ........................................................................... 3773Tiamulin for veterinary use................................................... 3774Tiamulin hydrogen fumarate for veterinary use................. 3777Tianeptine sodium.................................................................. 3779Tiapride hydrochloride .......................................................... 3781Tiaprofenic acid ...................................................................... 3782Tibolone................................................................................... 3783Ticarcillin sodium .................................................................. 3784Tick-borne encephalitis vaccine (inactivated) ...................... 988Ticlopidine hydrochloride ..................................................... 3786Tilidine hydrochloride hemihydrate .................................... 3788Timolol maleate ...................................................................... 3789Tinctures .................................................................................... 817Tinidazole ................................................................................ 3791Tinnevelly senna pods............................................................ 1519Tinzaparin sodium ................................................................. 3792Tioconazole ............................................................................. 3793Tiotropium bromide monohydrate ............................... 9.3-5004Titanium dioxide .................................................................... 3796Titration, amperometric (2.2.19.) ............................................. 35Titration, potentiometric (2.2.20.)............................................ 35Titrations, complexometric (2.5.11.)...................................... 164Titration, voltametric (2.2.65.)................................................ 112Tizanidine hydrochloride ...................................................... 3797Tobramycin.............................................................................. 3799Tocopherol, all-rac-α-............................................................. 3800Tocopherol, RRR-α-................................................................ 3801Tocopheryl acetate, all-rac-α- ............................................... 3802α-Tocopheryl acetate concentrate (powder form).............. 3805Tocopheryl acetate, RRR-α-................................................... 3804Tocopheryl hydrogen succinate, DL-α- ................................ 3806Tocopheryl hydrogen succinate, RRR-α- ............................. 3808Tolbutamide............................................................................. 3810Tolfenamic acid ....................................................................... 3811Tolnaftate ................................................................................. 3812Tolterodine tartrate................................................................. 3813Tolu balsam ............................................................................. 1541Toluenesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.40.)................................................................. 179

Torasemide .............................................................................. 3815Tormentil ................................................................................. 1542Tormentil tincture .................................................................. 1542Tosylchloramide sodium ....................................................... 3816Total ash (2.4.16.)...................................................................... 137Total cholesterol in oils rich in omega-3 acids (2.4.32.) ...... 157Total organic carbon in water for pharmaceutical use(2.2.44.) ...................................................................................... 73

Total protein (2.5.33.)............................................................... 172Toxicity, abnormal (2.6.9.)....................................................... 194Traditional Chinese medicine, names of herbal drugs used in(5.22.) .............................................................................. 9.3-4763

Tragacanth ............................................................................... 1543

5074 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

Tramadol hydrochloride ........................................................ 3817Tramazoline hydrochloride monohydrate........................... 3818Trandolapril............................................................................. 3819Tranexamic acid...................................................................... 3821Transdermal patches ................................................................ 873Transdermal patches, dissolution test for (2.9.4.)................. 309Trapidil..................................................................................... 3822Trehalose dihydrate ................................................................ 3823Tretinoin .................................................................................. 3824Triacetin ................................................................................... 3825Triamcinolone ......................................................................... 3826Triamcinolone acetonide ....................................................... 3827Triamcinolone hexacetonide ................................................. 3829Triamterene ............................................................................. 3830Tribenoside.............................................................................. 3832Tributyl acetylcitrate............................................................... 3833Trichloroacetic acid ................................................................ 3835Triclabendazole for veterinary use ....................................... 3836Triethanolamine...................................................................... 3849Triethyl citrate ......................................................................... 3837Trifluoperazine hydrochloride .............................................. 3837Triflusal .................................................................................... 3838Triglycerides, medium-chain ................................................ 3839Triglycerides, omega-3-acid .................................................. 3209Triglycerol diisostearate ......................................................... 3841Trihexyphenidyl hydrochloride ............................................ 3841Trimebutine maleate ....................................................... 9.3-5005Trimeprazine hemitartrate .................................................... 1666Trimetazidine dihydrochloride ............................................. 3843Trimethadione......................................................................... 3845Trimethoprim.......................................................................... 3846Trimipramine maleate............................................................ 3848Tri-n-butyl phosphate ............................................................ 3834Tritiated (3H) water injection ................................................ 1202Trolamine................................................................................. 3849Trometamol ............................................................................. 3851Tropicamide............................................................................. 3852Tropisetron hydrochloride..................................................... 3853Trospium chloride .................................................................. 3855Troxerutin......................................................................... 9.3-5007Trypsin ..................................................................................... 3857Tryptophan .............................................................................. 3858TSE, animal, minimising the risk of transmitting via humanand veterinary medicinal products (5.2.8.) ......................... 613

TSE, animal, products with risk of transmitting agents of.. 832Tuberculin for human use, old.............................................. 3861Tuberculin purified protein derivative, avian ..................... 3862Tuberculin purified protein derivative, bovine ................... 3863Tuberculin purified protein derivative for human use....... 3864Tuberculosis (BCG) vaccine, freeze-dried............................. 895Tubes for comparative tests (2.1.5.).......................................... 17Tubing and closures, silicone elastomer for (3.1.9.) ............. 409Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for(3.1.7.) ............................................................................. 9.2-4318

Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ............................................................ 393

Turkey infectious rhinotracheitis vaccine (live) ................. 1107Turmeric, Javanese.................................................................. 1544Turmeric rhizome................................................................... 1545Turpentine oil.......................................................................... 1547Tylosin for veterinary use ............................................... 9.3-5008Tylosin phosphate bulk solution for veterinary use .... 9.3-5012Tylosin phosphate for veterinary use ............................ 9.3-5017Tylosin tartrate for veterinary use ................................. 9.3-5021Typhoid polysaccharide and hepatitis A (inactivated,adsorbed) vaccine ................................................................... 929

Typhoid polysaccharide vaccine ............................................. 990Typhoid vaccine ........................................................................ 992Typhoid vaccine (live, oral, strain Ty 21a) ............................ 992Tyrosine ................................................................................... 3870Tyrothricin............................................................................... 3871

UUbidecarenone ........................................................................ 3875Udder-washes................................................................... 9.3-4793Ultraviolet and visible absorption spectrophotometry(2.2.25.) ...................................................................................... 41

Ultraviolet ray lamps for analytical purposes (2.1.3.) ............ 15Uncaria stem with hooks ................................................ 9.3-4821Uncoated tablets .............................................................. 9.3-4791Undecylenic acid..................................................................... 3876Uniformity of content of single-dose preparations (2.9.6.).. 312Uniformity of dosage units (2.9.40.) ............................. 9.1-4055Uniformity of dosage units, demonstration using large samplesizes (2.9.47.) ........................................................................... 384

Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) ................................................................. 347

Uniformity of mass of single-dose preparations (2.9.5.) ..... 311Units of the International System (SI) used in thePharmacopoeia and equivalence with other units(1.) ................................................................................... 9.2-4275

Unsaponifiable matter (2.5.7.)................................................. 163Urea .......................................................................................... 3877Urofollitropin .......................................................................... 3877Urokinase................................................................................. 3879Uronic acids in polysaccharide vaccines (2.5.22.) ................ 168Ursodeoxycholic acid ............................................................ 3880Urtica dioica for homoeopathic preparations..................... 1614

VVaccine component assay by immunonephelometry(2.7.35.) .................................................................................... 279

Vaccines, adsorbed, aluminium in (2.5.13.) .......................... 165Vaccines, adsorbed, calcium in (2.5.14.)................................ 166Vaccines and immunosera, phenol in (2.5.15.)..................... 166Vaccines and immunosera, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 612

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 610

Vaccines for human use ........................................................... 840Vaccines for human use, cell substrates for the production of(5.2.3.) ............................................................................. 9.3-4733

Vaccines for human use, conjugated polysaccharide, carrierproteins for the production of (5.2.11.) ............................... 626

Vaccines for human use, viral, tests for extraneous agents in(2.6.16.) ........................................................................... 9.3-4711

Vaccines for veterinary use...................................................... 843Vaccines for veterinary use, inactivated, healthy chicken flocksfor the production of (5.2.13.) .............................................. 630

Vaccines, polysaccharide, hexosamines in (2.5.20.) ............. 167Vaccines, polysaccharide, methylpentoses in (2.5.21.)......... 167Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............. 166Vaccines, polysaccharide, O-acetyl in (2.5.19.) ..................... 167Vaccines, polysaccharide, phosphorus in (2.5.18.) ............... 166Vaccines, polysaccharide, protein in (2.5.16.) ....................... 166Vaccines, polysaccharide, ribose in (2.5.31.)......................... 171Vaccines, polysaccharide, sialic acid in (2.5.23.) .................. 168Vaccines, polysaccharide, uronic acids in (2.5.22.) .............. 168Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ................................................................... 599

Vaccines, substitution of in vivo method(s) by in vitromethod(s) for the quality control of (5.2.14.) ............ 9.3-4737

Vaccines, veterinary, cell cultures for the production of(5.2.4.) ...................................................................................... 606

Vaccines, viral live, test for neurovirulence (2.6.18.) ........... 212Vaginal capsules ........................................................................ 888Vaginal foams............................................................................ 889Vaginal preparations ................................................................ 887Vaginal preparations, semi-solid ............................................ 889Vaginal solutions and suspensions, tablets for...................... 889Vaginal solutions, emulsions and suspensions...................... 888Vaginal tablets ........................................................................... 888Vaginal tampons, medicated ................................................... 889Valaciclovir hydrochloride ............................................. 9.3-5029

General Notices (1) apply to all monographs and other texts 5075

Index EUROPEAN PHARMACOPOEIA 9.3

Valaciclovir hydrochloride, hydrated ............................ 9.3-5032Valerian dry aqueous extract ............................................... 1549Valerian dry hydroalcoholic extract ..................................... 1550Valerian root..................................................................... 9.1-4111Valerian root, cut ............................................................. 9.1-4113Valerian tincture ..................................................................... 1554Validation of nucleic acid amplification techniques for thedetection of B19 virus (B19V) DNA in plasma pools :guidelines................................................................................. 214

Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :guidelines................................................................................. 214

Valine ....................................................................................... 3890Valnemulin hydrochloride for veterinary use .................... 3892Valproate, sodium................................................................... 3609Valproic acid............................................................................ 3893Valsartan .................................................................................. 3895Vancomycin hydrochloride ................................................... 3896Vanillin..................................................................................... 3898Vapour, preparations to be converted into............................ 876Vardenafil hydrochloride trihydrate..................................... 3898Varicella immunoglobulin for intravenous administration,human .................................................................................... 2700

Varicella immunoglobulin, human ...................................... 2700Varicella, measles, mumps and rubella vaccine (live) .......... 953Varicella vaccine (live) ............................................................. 994Vectors for human use, adenovirus ........................................ 742Vectors for human use, plasmid ............................................. 740Vectors for human use, plasmid, bacterial cells used for themanufacture of........................................................................ 741

Vectors for human use, poxvirus ............................................ 744Vecuronium bromide ...................................................... 9.1-4211Vedaprofen for veterinary use............................................... 3901Vegetable fatty oils .................................................................... 848Venlafaxine hydrochloride .................................................... 3902Verapamil hydrochloride ....................................................... 3904Verbena herb ........................................................................... 1555Veterinary liquid preparations for cutaneousapplication ...................................................................... 9.3-4792

Veterinary medicinal products, immunological, substances ofanimal origin for the production of (5.2.5.)........................ 608

Veterinary semi-solid preparations for oral use ................... 890Veterinary vaccines and immunosera, evaluation of efficacy of(5.2.7.) ...................................................................................... 612

Viability, nucleated cell count and (2.7.29.) .......................... 275Vibriosis (cold-water) vaccine (inactivated) forsalmonids........................................................................ 9.2-4428

Vibriosis vaccine (inactivated) for salmonids .............. 9.2-4429VICH (5.8.)....................................................................... 9.3-4741Vigabatrin ................................................................................ 3906Vinblastine sulfate .................................................................. 3907Vincristine sulfate ................................................................... 3908Vindesine sulfate.............................................................. 9.3-5034Vinorelbine tartrate ................................................................ 3912Vinpocetine ............................................................................. 3914Viper venom antiserum, European ...................................... 1119Viral diarrhoea vaccine (inactivated), bovine ..................... 1023Viral hepatitis type I vaccine (live), duck ............................ 1047Viral rhinotracheitis vaccine (inactivated), feline .............. 1059Viral rhinotracheitis vaccine (live), feline ........................... 1060Viral safety (5.1.7.).................................................................... 591Viral tenosynovitis vaccine (live), avian .............................. 1017Viral vaccines for human use, tests for extraneous agents in(2.6.16.) ........................................................................... 9.3-4711

Viscometer method, capillary (2.2.9.) ...................................... 27Viscometer methods, falling ball and automatic rolling ball(2.2.49.) ........................................................................... 9.3-4690

Viscose wadding, absorbent .................................................. 3915Viscosity (2.2.8.).......................................................................... 27Viscosity - rotating viscometer method (2.2.10.) ................... 28Visible and ultraviolet absorption spectrophotometry(2.2.25.) ...................................................................................... 41

Visible particles, particulate contamination (2.9.20.) .......... 337

Vitamin A ................................................................................ 3917Vitamin A concentrate (oily form), synthetic .............. 9.3-5036Vitamin A concentrate (powder form), synthetic ....... 9.3-5037Vitamin A concentrate (solubilisate/emulsion),synthetic.......................................................................... 9.3-5038

Voltametric titration (2.2.65.) ................................................. 112Volumetric analysis (4.2.) ........................................................ 565Volumetric solutions (4.2.2.) .......................................... 9.2-4325Volumetric solutions (4.2.2.) .......................................... 9.3-4730Volumetric solutions, primary standards for (4.2.1.) .. 9.2-4324von Willebrand factor, human.............................................. 2701von Willebrand factor, human, assay of (2.7.21.) ................. 268Voriconazole............................................................................ 3921

WWarfarin sodium..................................................................... 3927Warfarin sodium clathrate..................................................... 3928Washes, nasal............................................................................. 868Water (15O) injection .............................................................. 1203Water, determination by distillation (2.2.13.) ......................... 31Water for diluting concentrated haemodialysis solutions.. 2627Water for injections ......................................................... 9.1-4215Water for pharmaceutical use, total organic carbon in(2.2.44.) ...................................................................................... 73

Water for preparation of extracts.......................................... 3932Water, highly purified ............................................................ 3933Water in essential oils (2.8.5.) ................................................. 284Water in gases (2.5.28.) ............................................................ 170Water : micro determination (2.5.32.) .................................... 172Water, purified ........................................................................ 3935Water : semi-micro determination (2.5.12.) .......................... 165Water-solid interactions: determination of sorption-desorption isotherms and of water activity (2.9.39) .......... 369

Wettability of porous solids including powders (2.9.45.) .... 381Wheat-germ oil, refined......................................................... 3937Wheat-germ oil, virgin........................................................... 3938Wheat starch............................................................................ 3937White beeswax ........................................................................ 1804White horehound ................................................................... 1557White peony root.................................................................... 1472White soft paraffin.................................................................. 3270Wild pansy (flowering aerial parts)...................................... 1558Wild thyme.............................................................................. 1559Willow bark ............................................................................. 1561Willow bark dry extract ......................................................... 1562Wool alcohols .......................................................................... 3938Wool fat.................................................................................... 3939Wool fat, hydrogenated.......................................................... 3943Wool fat, hydrous.................................................................... 3944Wormwood.............................................................................. 1563

XXanthan gum.................................................................... 9.2-4627Xenon (133Xe) injection .......................................................... 1204X-ray fluorescence spectrometry (2.2.37.).................... 9.3-4689X-ray powder diffraction (XRPD), characterisation ofcrystalline and partially crystalline solids by (2.9.33.)....... 354

Xylazine hydrochloride for veterinary use .......................... 3948Xylitol ....................................................................................... 3949Xylometazoline hydrochloride.............................................. 3951Xylose ....................................................................................... 3953

YYarrow ...................................................................................... 1564Yeasticidal, bactericidal or fungicidal activity of antisepticmedicinal products, determination of (5.1.11.) ......... 9.2-4348

Yellow beeswax........................................................................ 1805Yellow fever vaccine (live) ....................................................... 996Yellow soft paraffin................................................................. 3271Yersiniosis vaccine (inactivated) for salmonids ........... 9.2-4430Yohimbine hydrochloride ...................................................... 3957

5076 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 9.3 Index

ZZanamivir hydrate .................................................................. 3961Zanthoxylum bungeanum pericarp...................................... 1565Zidovudine .............................................................................. 3962Zinc acetate dihydrate ............................................................ 3964Zinc acexamate ....................................................................... 3965Zinc chloride ........................................................................... 3967Zinc gluconate......................................................................... 3967Zinc oxide ................................................................................ 3968Zinc stearate ............................................................................ 3968

Zinc sulfate heptahydrate ...................................................... 3969Zinc sulfate hexahydrate ........................................................ 3970Zinc sulfate monohydrate...................................................... 3970Zinc undecylenate .................................................................. 3970Ziprasidone hydrochloride monohydrate............................ 3971Ziprasidone mesilate trihydrate ............................................ 3973Zolpidem tartrate.................................................................... 3975Zopiclone ................................................................................. 3976Zoster (shingles) vaccine (live), herpes.................................. 982Zuclopenthixol decanoate...................................................... 3978

General Notices (1) apply to all monographs and other texts 5077