Compendial Deferrals for USP41-NF36 · in vitro cell-based bioidentity test, additional...
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Compendial Deferrals for USP41-NF36 Category Monograph Title Monograph Section Scientific Liaison Revision USP AND NF EXCIPIENTS, LISTED BY CATEGORY PF 43(1) Pg. ONLINE {Emollient} Isopropyl Isostearate, {Emollient} Isostearyl Isostearate, {Emulsifying Agent} Isopropyl Isostearate, {Emulsifying Agent} Isostearyl Isostearate, {Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent}, {Emulsifying Agent} Glyceryl Tricaprylate, {Lubricant} Glyceryl Tricaprylate, {Vehicle (solid carrier)} Glyceryl Tricaprylate Hong Wang Revision <5> INHALATION AND NASAL DRUG PRODUCTS GENERAL INFORMATION AND PRODUCT QUALITY TESTS PF 43(1) Pg. ONLINE Introduction, 1. INTRODUCTION, 2. GENERAL QUALITY TESTS FOR INHALATION DRUG PRODUCTS, 3. GENERAL QUALITY TESTS FOR NASAL DRUG PRODUCTS, 4. DESCRIPTION OF PRODUCT QUALITY TESTS Kahkashan Zaidi New DESCRIPTION AND SOLUBILITY PF 43(1) Pg. ONLINE Bendamustine Hydrochloride, Isopropyl Isostearate, Isostearyl Isostearate, Ropivacaine, Bortezomib, Sodium Lauroyl Sarcosinate, Gatifloxacin, Carglumic Acid, Brimonidine Tartrate, Iloperidone, Glyceryl Tricaprylate, Oxiconazole Nitrate, Acamprosate Calcium, Frovatriptan Succinate, Nebivolol Hydrochloride, Solifenacin Succinate Feiwen Mao Revision <123> GLUCAGON BIOIDENTITY TESTS PF 41(2) Pg. ONLINE INTRODUCTION/Introduction, PROCEDURE/Assay, PROCEDURE/B. In Vitro Cell-Based Bioidentity Test, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Maura Kibbey Revision <467> RESIDUAL SOLVENTS PF 41(5) Pg. ONLINE INTRODUCTION, CLASSIFICATION OF RESIDUAL SOLVENTS BY RISK ASSESSMENT, METHODS FOR ESTABLISHING EXPOSURE LIMITS, OPTIONS FOR DESCRIBING LIMITS OF CLASS 2 RESIDUAL SOLVENTS, ANALYTICAL PROCEDURES, REPORTING LEVELS OF RESIDUAL SOLVENTS, LIMITS OF RESIDUAL SOLVENTS, IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS, GLOSSARY, APPENDIX 1. LIST, APPENDIX 2. ADDITIONAL BACKGROUND, APPENDIX 3. PROCEDURES FOR ESTABLISHING EXPOSURE LIMITS, INTRODUCTION, CONTROL STRATEGY, OPTIONS FOR DESCRIBING LIMITS FOR RESIDUAL SOLVENTS, SCREENING FOR WATER- SOLUBLE ARTICLES, PROCEDURE A, PROCEDURE B, SCREENING FOR WATER- INSOLUBLE ARTICLES, CLASS 3 RESIDUAL SOLVENTS, LIMIT TESTS WHEN SOLVENTS LTBP ARE KNOWN, QUANTITATIVE TESTS, QUANTIFICATION FOR WATER-INSOLUBLE ARTICLES, PROCEDURE C, VERIFICATION AND VALIDATION, VERIFICATION OF COMPENDIAL PROCEDURES, VALIDATION OF ALTERNATIVE PROCEDURES, APPENDICES Horacio Pappa New <509> RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Maura Kibbey Revision <601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND POWDERS--PERFORMANCE QUALITY TESTS PF 42(6) Pg. ONLINE TABLE OF CONTENTS, INTRODUCTION, A. DELIVERED-DOSE UNIFORMITYDELIVERED CONTENT UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS AND SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION-INHALATION AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi Revision <661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE PF 42(4) Pg. ONLINE SCOPE, TEST METHODS, FUNCTIONALITY Desmond Hunt New <856> NEAR-INFRARED SPECTROSCOPY PF 42(2) Pg. ONLINE 2. QUALIFICATION OF NIR SPECTROMETERS, 3. PROCEDURE, 4. VALIDATION AND VERIFICATION, 1. INTRODUCTION, 2. QUALIFICATION OF NIR SPECTROMETERS, USP REFERENCE STANDARDS <11> Kahkashan Zaidi New <858> RAMAN SPECTROSCOPY PF 42(2) Pg. ONLINE Introduction, QUALIFICATION OF RAMAN SPECTROMETERS, VALIDATION AND VERIFICATION, Title, Introduction, PROCEDURE, VERIFICATION Kahkashan Zaidi
Transcript of Compendial Deferrals for USP41-NF36 · in vitro cell-based bioidentity test, additional...
Compendial Deferrals for USP41-NF36
Category Monograph Title Monograph Section Scientific Liaison
Revision USP AND NF EXCIPIENTS, LISTED BY CATEGORY PF 43(1) Pg. ONLINE
{Emollient} Isopropyl Isostearate, {Emollient} Isostearyl Isostearate, {Emulsifying Agent} Isopropyl Isostearate, {Emulsifying Agent} Isostearyl Isostearate, {Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent}, {Emulsifying Agent} Glyceryl Tricaprylate, {Lubricant} Glyceryl Tricaprylate, {Vehicle (solid carrier)} Glyceryl Tricaprylate Hong Wang
Revision<5> INHALATION AND NASAL DRUG PRODUCTS GENERAL INFORMATION AND PRODUCT QUALITY TESTS PF 43(1) Pg. ONLINE
Introduction, 1. INTRODUCTION, 2. GENERAL QUALITY TESTS FOR INHALATION DRUG PRODUCTS, 3. GENERAL QUALITY TESTS FOR NASAL DRUG PRODUCTS, 4. DESCRIPTION OF PRODUCT QUALITY TESTS Kahkashan Zaidi
New DESCRIPTION AND SOLUBILITY PF 43(1) Pg. ONLINE
Bendamustine Hydrochloride, Isopropyl Isostearate, Isostearyl Isostearate, Ropivacaine, Bortezomib, Sodium Lauroyl Sarcosinate, Gatifloxacin, Carglumic Acid, Brimonidine Tartrate, Iloperidone, Glyceryl Tricaprylate, Oxiconazole Nitrate, Acamprosate Calcium, Frovatriptan Succinate, Nebivolol Hydrochloride, Solifenacin Succinate Feiwen Mao
Revision <123> GLUCAGON BIOIDENTITY TESTS PF 41(2) Pg. ONLINEINTRODUCTION/Introduction, PROCEDURE/Assay, PROCEDURE/B. In Vitro Cell-Based Bioidentity Test, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Maura Kibbey
Revision <467> RESIDUAL SOLVENTS PF 41(5) Pg. ONLINE
INTRODUCTION, CLASSIFICATION OF RESIDUAL SOLVENTS BY RISK ASSESSMENT, METHODS FOR ESTABLISHING EXPOSURE LIMITS, OPTIONS FOR DESCRIBING LIMITS OF CLASS 2 RESIDUAL SOLVENTS, ANALYTICAL PROCEDURES, REPORTING LEVELS OF RESIDUAL SOLVENTS, LIMITS OF RESIDUAL SOLVENTS, IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS, GLOSSARY, APPENDIX 1. LIST, APPENDIX 2. ADDITIONAL BACKGROUND, APPENDIX 3. PROCEDURES FOR ESTABLISHING EXPOSURE LIMITS, INTRODUCTION, CONTROL STRATEGY, OPTIONS FOR DESCRIBING LIMITS FOR RESIDUAL SOLVENTS, SCREENING FOR WATER-SOLUBLE ARTICLES, PROCEDURE A, PROCEDURE B, SCREENING FOR WATER-INSOLUBLE ARTICLES, CLASS 3 RESIDUAL SOLVENTS, LIMIT TESTS WHEN SOLVENTS LTBP ARE KNOWN, QUANTITATIVE TESTS, QUANTIFICATION FOR WATER-INSOLUBLE ARTICLES, PROCEDURE C, VERIFICATION AND VALIDATION, VERIFICATION OF COMPENDIAL PROCEDURES, VALIDATION OF ALTERNATIVE PROCEDURES, APPENDICES Horacio Pappa
New <509> RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE
Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Maura Kibbey
Revision<601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND POWDERS--PERFORMANCE QUALITY TESTS PF 42(6) Pg. ONLINE
TABLE OF CONTENTS, INTRODUCTION, A. DELIVERED-DOSE UNIFORMITYDELIVERED CONTENT UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS AND SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION-INHALATION AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi
Revision<661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE PF 42(4) Pg. ONLINE SCOPE, TEST METHODS, FUNCTIONALITY Desmond Hunt
New <856> NEAR-INFRARED SPECTROSCOPY PF 42(2) Pg. ONLINE
2. QUALIFICATION OF NIR SPECTROMETERS, 3. PROCEDURE, 4. VALIDATION AND VERIFICATION, 1. INTRODUCTION, 2. QUALIFICATION OF NIR SPECTROMETERS, USP REFERENCE STANDARDS <11> Kahkashan Zaidi
New <858> RAMAN SPECTROSCOPY PF 42(2) Pg. ONLINEIntroduction, QUALIFICATION OF RAMAN SPECTROMETERS, VALIDATION AND VERIFICATION, Title, Introduction, PROCEDURE, VERIFICATION Kahkashan Zaidi
Revision<1090> ASSESSMENT OF DRUG PRODUCT PERFORMANCE--BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION PF 42(4) Pg. ONLINE
Title, BACKGROUND, BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION, BIOEQUIVALENCE, DISSOLUTION AND IN VITRO PRODUCT PERFORMANCE, BIOWAIVER, APPENDIX William Brown
Revision <1119> NEAR-INFRARED SPECTROSCOPY PF 41(1) Pg. ONLINE
INTRODUCTION, INSTRUMENTATION, METHOD VALIDATION, GLOSSARY, *No Head*, 1. THEORY, 2. TRANSMISSION, REFLECTION, AND TRANSFLECTION MODES, 3. FACTORS THAT AFFECT NIR SPECTRA, 4. PRETREATMENT OF NIR SPECTRAL DATA, 5. INSTRUMENTATION, 6. APPLICATIONS, 7. PROCEDURE VALIDATION, 8. APPENDIX: GLOSSARY Kahkashan Zaidi
Revision <1120> RAMAN SPECTROSCOPY PF 40(6) Pg. ONLINE
Title, INTRODUCTION, QUALITATIVE AND QUANTITATIVE RAMAN MEASUREMENTS, FACTORS AFFECTING QUANTIFICATION, APPARATUS, QUALIFICATION AND VERIFICATION OF RAMAN SPECTROMETERS, METHOD VALIDATION, DEFINITION OF TERMS AND SYMBOLS, THEORY, SAMPLING FACTORS, SPECIALIZED TECHNIQUES, CALIBRATION, FACTORS THAT AFFECT MEASUREMENT PERFORMANCE, PROCEDURE VALIDATION Kahkashan Zaidi
New ACAMPROSATE DELAYED-RELEASE TABLETS PF 41(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Limit of Acamprosate Related Compound A, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acamprosate Calcium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acamprosate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acamprosate Related Compound B RS Heather Joyce
Revision ACETAMINOPHEN ORAL SUSPENSION PF 42(6) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities Clydewyn Anthony
Revision ACETAMINOPHEN TABLETS PF 42(3) Pg. ONLINEIDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure Clydewyn Anthony
New
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE ORAL SUSPENSION PF 42(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Deliverable Volume <698>, IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetaminophen RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Aminophenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorpheniramine Maleate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Hydrochloride RS Clydewyn Anthony
NewACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 42(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetaminophen RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Aminophenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guaifenesin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound F RS Clydewyn Anthony
NewACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 42(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetaminophen RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guaifenesin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound F RS Clydewyn Anthony
Revision ACETAZOLAMIDE TABLETS PF 42(6) Pg. ONLINE
ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetazolamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetazolamide Related Compound E RS Ramanujam Prasad
Revision ALBUMIN HUMAN PF 41(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Immunodiffusion, IDENTIFICATION/B. Protein Composition by Zone Electrophoresis, ASSAY/Procedure, OTHER COMPONENTS/Content of Sodium Caprylate, OTHER COMPONENTS/Content of N-Acetyl-dl-tryptophan, IMPURITIES/Prekallikrein Activator <165>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Biological Reactivity tests <88>, In Vivo, Safety Tests-Biologicals, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Molecular Weight Distribution, SPECIFIC TESTS/Heat Stability, SPECIFIC TESTS/Content of Sodium, SPECIFIC TESTS/Limit of Potassium, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Kevin Carrick
Revision ALBUTEROL TABLETS PF 41(5) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B. Identification Tests-General, Sulfate <191>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levalbuterol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levalbuterol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levalbuterol Related Compound E RS Mary Koleck
Revision ALCLOMETASONE DIPROPIONATE CREAM PF 43(1) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate RS Mary Koleck
Revision ALCLOMETASONE DIPROPIONATE OINTMENT PF 43(1) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate RS Mary Koleck
Revision ALPRAZOLAM TABLETS PF 41(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alprazolam Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlordiazepoxide Related Compound A RS Heather Joyce
Revision AMOXICILLIN FOR ORAL SUSPENSION PF 42(6) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound H RS Ramanujam Prasad
New ANNATTO SEED TOCOTRIENOLS EXTRACT PF 42(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Procedure, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Water Determination <921>, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Annatto Seed Tocotrienols Extract RS Huy Dinh
Revision ASHWAGANDHA ROOT PF 42(2) Pg. ONLINE COMPOSITION/Content of Withanolides, ADDITIONAL REQUIREMENTS/Labeling Anton Bzhelyansky
Revision POWDERED ASHWAGANDHA ROOT PF 42(2) Pg. ONLINE
{Title} Ashwagandha Root Powder, DEFINITION/Introduction, IDENTIFICATION/Thin-Layer Chromatography, COMPOSITION/Content of Withanolides, SPECIFIC TESTS/Limit of Flavonol Glycosides Derived from Aerial Parts, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ashwagandha Aerial Parts Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Kaempferol 3-O-Robinoside-7-O-glucoside RS Anton Bzhelyansky
Revision POWDERED ASHWAGANDHA ROOT EXTRACT PF 42(2) Pg. ONLINE
{Title} Ashwagandha Root Dry Extract, DEFINITION/Introduction, IDENTIFICATION/Thin-Layer Chromatographic Identification Test <201>, COMPOSITION/Content of Withanolides, SPECIFIC TESTS/Limit of Flavonol Glycosides Derived from Aerial Parts, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ashwagandha Aerial Parts Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Kaempferol 3-O-Robinoside-7-O-glucoside RS Anton Bzhelyansky
Revision ASPIRIN PF 41(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197K> or <197A>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Substances Insoluble in Sodium Carbonate TS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid RS Clydewyn Anthony
Revision ATROPINE PF 43(1) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Foreign Alkaloids and Other Impurities, IMPURITIES/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Atropine RS Heather Joyce
New BACILLUS COAGULANS PF 43(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/Nucleic Acid-Based Identification, ASSAY/Enumeration, SPECIFIC TESTS/Loss on Drying <731>, CONTAMINANTS/Yeasts, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Escherichia coli and Test for Absence of Salmonella Species, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Seong Jae Yoo
New BACILLUS COAGULANS CAPSULES PF 43(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/Nucleic Acid-Based Identification, ASSAY/Enumeration, PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Disintegration, PERFORMANCE TESTS/Weight Variation <2091>, CONTAMINANTS/Yeasts, CONTAMINANTS/Coliforms, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Escherichia coli and Test for Absence of Salmonella Species, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Seong Jae Yoo
Revision BACLOFEN TABLETS PF 42(5) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Immediate-Release Dosage Forms, Procedure for a pooled sample, IMPURITIES/Organic Impurities Heather Joyce
Omission BCG VACCINE PF 43(1) Pg. ONLINE Entire document Dibyendu Saha
New BENDAMUSTINE HYDROCHLORIDE PF 43(1) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C16H21Cl2N3O2·HCl, Chemical Info/394.72, Chemical Info/1H-Benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, monohydrochloride;, Chemical Info/4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazole-2-yl}butanoic acid monohydrochloride, Chemical Info/CAS, Chemical Info/Bendamustine (free base), Chemical Info/C16H21Cl2N3O2, Chemical Info/358.26, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound I RS Feiwen Mao
New BENDAMUSTINE HYDROCHLORIDE FOR INJECTION PF 43(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, PERFORMANCE TESTS/ Uniformity of Dosage Units <905>, Weight Variation, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/ Sterility Tests <71>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling <7>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound I RS Feiwen Mao
Revision BENZETHONIUM CHLORIDE PF 42(6) Pg. ONLINEIDENTIFICATION/Infrared Absorption <197K>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Sujatha Ramakrishna
New BENZIL PF 42(4) Pg. ONLINE Benzil Hillary Cai
Revision BETAMETHASONE ACETATE PF 42(5) Pg. ONLINE
IDENTIFICATION/Infrared Absorption <197M>, IDENTIFICATION/Thin-Layer Chromatographic Identification Test <201>, ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Acetate Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Acetate Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS Mary Koleck
Revision BETAMETHASONE DIPROPIONATE CREAM PF 42(6) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound C RS Mary Koleck
Revision BETAMETHASONE DIPROPIONATE LOTION PF 42(6) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound C RS Mary Koleck
RevisionBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTABLE SUSPENSION PF 42(5) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Acetate Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Acetate Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS Mary Koleck
New BIVALIRUDIN PF 41(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C98H138N24O33, Chemical Info/2180.29 (free base), Chemical Info/l-Leucine, d-phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-α-aspartyl-l-phenylalanyl-l-α-glutamyl-l-α-glutamyl-l-isoleucyl-l-prolyl-l-α-glutamyl-l-α-glutamyl-l-tyrosyl-;, Chemical Info/d-Phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-α-aspartyl-l-phenylalanyl-l-α-glutamyl-l-α-glutamyl-l-isoleucyl-l-prolyl-l-α-glutamyl-l-α-glutamyl-l-tyrosyl-l-leucine, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A, IDENTIFICATION/B., IDENTIFICATION/C. Amino Acid Content, IDENTIFICATION/D. Bioidentity, ASSAY/Procedure, ASSAY/Product-Related Substances and Impurities, OTHER COMPONENTS/Trifluoroacetic Acid (TFA) in Peptides <503.1>, SPECIFIC TESTS/Microbial Enumeration Tests <61>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Water Determination <921>, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [Asp9]-Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [des-Glu13]-Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Elena Curti
New BIVALIRUDIN FOR INJECTION PF 41(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Bioidentity, ASSAY/Procedure, ASSAY/Product-Related Substances and Impurities, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, SPECIFIC TESTS/Completeness of Solution <641>, SPECIFIC TESTS/Constituted Solution, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, Test for Sterility of the Product to Be Examined, Membrane Filtration, SPECIFIC TESTS/Water Determination <921>, Method Ic, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [Asp9]-Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Elena Curti
New BORTEZOMIB PF 42(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C19H25BN4O4, Chemical Info/384.24 (boronic acid form), Chemical Info/Boronic acid, [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]-;, Chemical Info/{(R)-3-Methyl-1-[(S)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido]butyl}boronic acid;, Chemical Info/N-[(1S)-1-Benzyl-2-[[(1R)-1-(dihydroxyboranyl)-3-methylbutyl]amino]-2-oxoethyl]pyrazinecarboxamide, Chemical Info/CAS, Chemical Info/C57H69B3N12O9, Chemical Info/1098.67 (trimeric boroxine form), DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bortezomib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bortezomib Related Compound A RS Feiwen Mao
New BORTEZOMIB FOR INJECTION PF 42(6) Pg. ONLINE
Title, DEFINITION/Introduction, DEFINITION/Note, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/ Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling <7>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bortezomib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bortezomib Related Compound A RS Feiwen Mao
New BRIMONIDINE TARTRATE PF 42(4) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C11H10BrN5·C4H6O6, Chemical Info/442.22, Chemical Info/6-Quinoxalinamine, 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1);, Chemical Info/5-Bromo-6-(2-imidazolin-2-ylamino)quinoxaline l-tartrate (1:1)., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Brimonidine Tartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Brimonidine Related Compound E RS Ramanujam Prasad
New BUDESONIDE DELAYED-RELEASE CAPSULES PF 42(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound L RS Mary Koleck
Revision BUPIVACAINE HYDROCHLORIDE PF 41(3) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197S>, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Chromatographic Purity, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ropivacaine Related Compound A, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine Related Compound A RS Mary Koleck
Revision BUPIVACAINE HYDROCHLORIDE INJECTION PF 41(3) Pg. ONLINE
IDENTIFICATION/A. Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Related Compound B RS Mary Koleck
Revision BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION PF 41(3) Pg. ONLINE
IDENTIFICATION/C., ASSAY/Bupivacaine Hydrochloride, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Related Compound B RS Mary Koleck
Revision CARBINOXAMINE MALEATE PF 42(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197M><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound C RS Mary Koleck
Revision CARBINOXAMINE MALEATE TABLETS PF 42(2) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound B RS Mary Koleck
New CARGLUMIC ACID PF 41(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C6H10N2O5, Chemical Info/190.15, Chemical Info/l-Glutamic acid, N-(aminocarbonyl)-;, Chemical Info/N-Carbamoyl-l-glutamic acid, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of d-Carglumic acid, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Optical Rotation <781>, Procedures, Specific Rotation, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carglumic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP d-Carglumic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carglumic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carglumic Acid Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carglumic Acid Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Glutamic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyroglutamic Acid RS Sujatha Ramakrishna
Revision CASTOR OIL PF 41(5) Pg. ONLINE
Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Identity by Fatty Acid Composition, IDENTIFICATION/B. Distinction from Most Other Fixed Oils, ASSAY/Triglyceride Composition, SPECIFIC TESTS/Distinction from Most Other Fixed Oils, SPECIFIC TESTS/Fats and Fixed Oils <401>, Free Fatty Acids, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Hydroxyl Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Fats and Fixed Oils, Iodine Value <401>, SPECIFIC TESTS/Fats and Fixed Oils <401>, Unsaponifiable Matter, SPECIFIC TESTS/Water Determination <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/Other Requirements, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang
New CHELATING ION EXCHANGE RESIN PF 41(3) Pg. ONLINE Chelating Ion-Exchange Resin Trish LiNew 2-CHLOROBENZOPHENONE PF 42(3) Pg. ONLINE 2-Chlorobenzophenone, Ramanujam Prasad
New CHOLINE FENOFIBRATE PF 42(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C22H28ClNO5, Chemical Info/421.91, Chemical Info/Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, salt with 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (1:1);, Chemical Info/2-Hydroxy-N,N,N-trimethylethanaminium 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Choline Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Choline Fenofibrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibrate Related Compound C RS Edith Chang
New CINACALCET TABLETS PF 42(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cinacalcet Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cinacalcet Related Compound A RS Elena Gonikberg
New CINACALCET HYDROCHLORIDE PF 42(4) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C22H22F3N·HCl, Chemical Info/393.87, Chemical Info/1-Naphthalenemethanamine, α-methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-, (αR)-, hydrochloride;, Chemical Info/N-[(1R)-1-(Naphthalen-1-yl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine hydrochloride, Chemical Info/CAS, Chemical Info/Cinacalcet (free base), Chemical Info/C22H22F3N, Chemical Info/373.94, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B. Identification Tests-General <191>, Chloride, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Cinacalcet Related Compound A, IMPURITIES/Enantiomeric and Isomeric Purity, SPECIFIC TESTS/Water Determination <921>, Method 1, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cinacalcet Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cinacalcet Related Compound A RS Cinacalcet mesylate analog; 3-[3-(Trifluoromethyl)phenyl]propyl methanesulfonate.C11H13F3O3S282.28, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cinacalcet Related Compound B RS Cinacalcet tertiary amine; (R)-N-[1-(Naphthalen-1-yl)ethyl]-3-[3-(trifluoromethyl)phenyl]-N-{3-[3-(trifluoromethyl)phenyl]propyl}propan-1-amine.C32H31F6N543.60, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cinacalcet Related Compound C RS para-Cinacalcet; (R)-N-[1-(Naphthalen-1-yl)ethyl]-3-[4-(trifluoromethyl)phenyl]propan-1-amine hydrochloride.C22H22F3N·HCl393.87, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cinacalcet Related Compound D RS Cinacalcet S-enantiomer; (S)-N-[1-(Naphthalen-1-yl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine hydrochloride.C22H22F3N·HCl393.87, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cinacalcet Related Compound E RS Cinacalcet alcohol; 3-[3-(Trifluoromethyl)phenyl]propan-1-ol.C10H11F3O204.19 Elena Gonikberg
New CITICOLINE SODIUM PF 42(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C14H25N4NaO11P2, Chemical Info/510.31, Chemical Info/Cytidine 5\'-(trihydrogen diphosphate), P\'-[2-(trimethylammonio)ethyl] ester, inner salt, monosodium salt;, Chemical Info/CDP-choline (sodium), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Chloride and Sulfate <221>, Chloride, IMPURITIES/Related Compounds, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Citicoline Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 5′-Cytidylic Acid RS Huy Dinh
Revision CLOMIPRAMINE HYDROCHLORIDE PF 42(3) Pg. ONLINE
IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Heavy Metals, Method II <231>, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound F RS Heather Joyce
Revision CLOMIPRAMINE HYDROCHLORIDE CAPSULES PF 42(3) Pg. ONLINE
IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound C RS Heather Joyce
Revision CLOTRIMAZOLE CREAM PF 42(3) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> Shankari Shivaprasad
New COFFEE FRUIT DRY EXTRACT PF 42(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids, CONTAMINANTS/Elemental Impurities-Procedures <233>, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella species and Test Procedures, Test for Absence of Escherichia coli, SPECIFIC TESTS/Limit of Caffeine, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coffee Fruit Dry Extract RS Cuiying Ma
New COIX SEED PF 42(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Triglycerides, CONTAMINANTS/Limit of Zearalenone, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella species and Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coix Seed Oil Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oleic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triolein RS Cuiying Ma
New COIX SEED POWDER PF 42(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Triglycerides, CONTAMINANTS/Limit of Zearalenone, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella species and Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coix Seed Oil Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oleic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triolein RS Cuiying Ma
Revision CYCLOPHOSPHAMIDE FOR INJECTION PF 43(1) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities: Procedure for the Sterile Powder Formulation, IMPURITIES/Organic Impurities: Procedure for the Lyophilized Formulation, IMPURITIES/Limit of Cyclophosphamide Related Compound C: Procedure for the Lyophilized Formulation, SPECIFIC TESTS/Limit of Chloride for the Lyophilized Formulation, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound D RS Feiwen Mao
Revision CYCLOSPORINE PF 43(1) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Slavica Shane
Revision CYCLOSPORINE CAPSULES PF 43(1) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure for Where Capsules Contain Liquid, ASSAY/Procedure for Where Capsules Contain Powder, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclosporine Resolution Mixture RS Slavica Shane
Revision CYCLOSPORINE INJECTION PF 43(1) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, OTHER COMPONENTS/Content of Alcohol (where present), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclosporine Resolution Mixture RS Slavica Shane
Revision CYCLOSPORINE ORAL SOLUTION PF 43(1) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, OTHER COMPONENTS/Content of Alcohol (where present), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclosporine Resolution Mixture RS Slavica Shane
Revision CYPROHEPTADINE HYDROCHLORIDE TABLETS PF 43(1) Pg. ONLINE IMPURITIES/Organic Impurities Mary Koleck
New DARIFENACIN HYDROBROMIDE PF 42(2) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C28H30N2O2·HBr, Chemical Info/507.46, Chemical Info/3-Pyrrolidineacetamide, 1-[2-(2,3-dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-, monohydrobromide, (3S)-;, Chemical Info/(S)-2-{1-[2-(2,3-Dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide, Chemical Info/CAS, Chemical Info/Darifenacin, Chemical Info/C28H30N2O2, Chemical Info/426.55, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Bromide, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Darifenacin Chiral Peak Identification Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Darifenacin Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Darifenacin Peak Identification Mixture RS Elena Gonikberg
New DESCHLOROCLOTRIMAZOLE PF 42(1) Pg. ONLINE Deschloroclotrimazole Ramanujam Prasad
Revision DESOXIMETASONE PF 42(1) Pg. ONLINEIDENTIFICATION/B. Thin-Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure Mary Koleck
Revision DEXAMETHASONE PF 42(4) Pg. ONLINE
IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desoximetasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS Mary Koleck
Revision DEXTROSE EXCIPIENT PF 42(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Related Substances, SPECIFIC TESTS/Optical Rotation <781S>, Specific Rotation, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Galina Holloway
New 7,8-DIHYDROFOLIC ACID PF 42(5) Pg. ONLINE 7,8-Dihydrofolic Acid K. Seela
Revision DIPYRIDAMOLE TABLETS PF 41(3) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound F RS Sujatha Ramakrishna
Revision DOXYLAMINE SUCCINATE PF 42(3) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/B. Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Volatile Related Compounds, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class I <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound C RS Richard Nguyen
Revision DOXYLAMINE SUCCINATE TABLETS PF 42(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound C RS Richard Nguyen
Revision EPINEPHRINE PF 42(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Adrenalone, IMPURITIES/Limit of Norepinephrine, IMPURITIES/Enantiomeric Purity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Adrenalone Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norepinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Racepinephrine Hydrochloride RS Sujatha Ramakrishna
New EPTACOG ALFA ACTIVATED PF 41(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C1982H3054N560O618S28, Chemical Info/INS: (The chemical formula includes the γ-carboxylations and modification of D (Asp) in position 63, and does not include the glycosylations.), Chemical Info/≊50,000 (The molecular weight includes the glycosylation.), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Peptide Mapping, ASSAY/Concentration of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Gla-Domainless Eptacog Alfa (γ-Carboxylation), IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, IMPURITIES/Non-Activated Factor VII (Single Chain), SPECIFIC TESTS/Glycan Analysis, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa for Bioassay RS Kevin Carrick
New EPTACOG ALFA ACTIVATED FOR INJECTION PF 41(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Content of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, SPECIFIC TESTS/Water Determination <921>, Method 1c, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, Test for Sterility of the Product to Be Examined, Membrane Filtration, SPECIFIC TESTS/Constituted Solution, ADDITIONAL REQUIREMENTS/Packaging and Storage Requirements <659>, Injection Packaging, Sterile solids packaging, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa for Bioassay RS Kevin Carrick
New ESTRIOL COMPOUNDED VAGINAL CREAM PF 42(5) Pg. ONLINE
Title, DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Estriol RS Jeanne Sun
New EVEROLIMUS PF 42(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C53H83NO14, Chemical Info/958.22, Chemical Info/(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone;, Chemical Info/(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Alcohol, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Sirolimus, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Organisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Everolimus RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Everolimus System Suitability Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sirolimus RS Morgan Puderbaugh
New FENOFIBRIC ACID DELAYED-RELEASE CAPSULES PF 42(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibric Acid RS Edith Chang
Revision FLECAINIDE ACETATE PF 42(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> <197>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Clarity of Solution Sujatha Ramakrishna
Revision FLECAINIDE ACETATE TABLETS PF 42(2) Pg. ONLINE
IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Sujatha Ramakrishna
Revision FLUDROCORTISONE ACETATE TABLETS PF 43(1) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone RS Gerald Hsu
New FLUVASTATIN EXTENDED-RELEASE TABLETS PF 42(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluvastatin Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluvastatin for System Suitability RS Sujatha Ramakrishna
Revision FLUVOXAMINE MALEATE TABLETS PF 42(5) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Test 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Heather Joyce
Revision FONDAPARINUX SODIUM PF 42(5) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fondaparinux Sodium System Suitability Mixture B RS Kevin Carrick
Revision FONDAPARINUX SODIUM INJECTION PF 42(5) Pg. ONLINEIDENTIFICATION/B. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85> Kevin Carrick
New FROVATRIPTAN TABLETS PF 41(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Frovatriptan Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Frovatriptan Related Compound A RS Heather Joyce
New FROVATRIPTAN SUCCINATE PF 41(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C14H17N3O·C4H6O4·H2O, Chemical Info/379.41, Chemical Info/(+)-(R)-2,3,4,9-Tetrahydro-3-(methylamino)-1H-carbazole-6-carboxamide butanedioate (1:1), monohydrate;, Chemical Info/(+)-(R)-5,6,7,8-Tetrahydro-6-(methylamino)carbazole-3-carboxamide succinate (1:1), monohydrate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Palladium, IMPURITIES/Limit of d-Camphor Sulfonic Acid, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP d-Camphor Sulfonic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Frovatriptan Racemate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Frovatriptan Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Frovatriptan Succinate RS Heather Joyce
New GATIFLOXACIN PF 42(6) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C19H22FN3O4, Chemical Info/375.40, Chemical Info/Quinoline-3-carboxylic acid, 1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-1,4-dihydro, (±);, Chemical Info/(±)-1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, Chemical Info/CAS, Chemical Info/Sesquihydrate, Chemical Info/402.42, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin Related Compound E RS Shankari Shivaprasad
New GATIFLOXACIN OPHTHALMIC SOLUTION PF 42(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Osmolality and Osmolarity <785>, SPECIFIC TESTS/Particulate Matter in Ophthalmic Solutions <789>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin Related Compound D RS Shankari Shivaprasad
New GLYCERYL TRICAPRYLATE PF 42(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C27H50O6, Chemical Info/470.68, Chemical Info/Octanoic acid, 1,1\',1\\'\'-(1,2,3-propanetriyl) ester;, Chemical Info/Octanoic acid, 1,2,3-propanetriyl ester;, Chemical Info/1,3-Di(octanoyloxy)propan-2-yl octanoate;, Chemical Info/ Glyceryl trioctanoate;, Chemical Info/Tricapryloylglycerol, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Fatty Acid Composition, IDENTIFICATION/B. Content of Triglycerides, IDENTIFICATION/C. Fats and Fixed Oils <401>, Saponification Value, ASSAY/Content of Triglycerides, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Alkaline Impurities, IMPURITIES/Limit of Free Glycerin, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Hydroxyl Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Glyceryl Monocaprylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Glyceryl Tricaprylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Caprate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Caproate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Caprylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Laurate RS Hong Wang
New GUANIDINE HYDROCHLORIDE PF 42(4) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/CH5N3·HCl, Chemical Info/95.53, Chemical Info/Guanidine, hydrochloride (1:1);, Chemical Info/Guanidine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Chloride and Sulfate <221>, Sulfate, IMPURITIES/Limit of Nitrate, IMPURITIES/Limit of Cyanide, IMPURITIES/Residue on Ignition <281>, SPECIFIC TESTS/Acidity, SPECIFIC TESTS/Water-Insoluble Substances, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class 1, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guanidine Hydrochloride RS Galina Holloway
Revision HYDROXYZINE HYDROCHLORIDE INJECTION PF 41(1) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Limit of 4-Chlorobenzophenone, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydroxyzine Related Compound A RS 1-[(4-Chlorophenyl)phenylmethyl]piperazine.C17H19ClN2286.80 Heather Joyce
New ILOPERIDONE PF 42(1) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C24H27FN2O4, Chemical Info/426.48, Chemical Info/Ethanone, 1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]-;, Chemical Info/4′-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3′-methoxyacetophenone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chloropropyl Vanillin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iloperidone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iloperidone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Paliperidone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Vanillin RS Heather Joyce
New ISOPROPYL ISOSTEARATE PF 43(1) Pg. ONLINE
Title, Chemical Info/INS: Isooctadecanoic acid, 1-methylethyl ester contains mainly isomers of isopropyl branched stearates., Chemical Info/Chemical Structure, Chemical Info/C21H42O2, Chemical Info/326.56, Chemical Info/Isooctadecanoic acid, 1-methylethyl ester, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or <197F>, IDENTIFICATION/B., ASSAY/Content of Isopropyl Fatty Esters, IMPURITIES/Residue on Ignition <281>, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Hydroxyl Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Iodine Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Saponification Value, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isopropyl Isostearate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isopropyl Myristate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isopropyl Palmitate RS Hong Wang
Revision ISOSORBIDE DINITRATE TABLETS PF 42(5) Pg. ONLINEIDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Sujatha Ramakrishna
New L##_EPTACOG alfa, Dionex CarboPac PA100 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex CarboPac PA100) Trish LiNew L##_EPTACOG alfa, Dionex DNAPac PA100 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex DNAPac PA100) Trish LiNew L107 PF 40(6) Pg. ONLINE L## (Rosuvastatin Calcium, CHIRALCEL OJ-RH) Sujatha Ramakrishna
Revision LEUCOVORIN CALCIUM PF 42(5) Pg. ONLINE
IDENTIFICATION/Infrared Absorption<197K>, IDENTIFICATION/B. Identification Tests-General <191> , Calcium, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of 5-(γ-Folinoyl)tetrahydrofolate, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Folic Acid RS Feiwen Mao
New LEUCOVORIN CALCIUM FOR INJECTION PF 42(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Folic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Leucovorin Calcium RS Feiwen Mao
Revision LEVONORGESTREL PF 41(5) Pg. ONLINEIDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Limit of Ethynyl Group, IMPURITIES/Organic Impurities Gerald Hsu
New CONJUGATED LINOLEIC ACIDS-TRIGLYCERIDES PF 42(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IMPURITIES/Limit of Polymerized Triglycerides, IMPURITIES/Limit of Benzo[a]pyrene, IMPURITIES/Elemental Impurities-Procedures <233>, IMPURITIES/Residual Solvents <467>, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Saponification Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Unsaponifiable Matter, SPECIFIC TESTS/Fats and Fixed Oils, <401>, Fatty Acid Composition, SPECIFIC TESTS/Content of Conjugated Linoleic Acids-Tri, Di, and Monoglycerides, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Conjugated Linoleic Acids-Triglycerides RS Huy Dinh
Revision MEFENAMIC ACID CAPSULES PF 42(5) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 2,3-Dimethylaniline RS Hillary Cai
Revision MEGESTROL ACETATE PF 42(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate RSUSP Megestrol Acetate Related Compound C RS 6,13aβ-Dimethyl-3,17-dioxo-13(17)a-homoandrosta-4,6-diene-13a-yl acetate.(C24H34O4386.52 ) USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene-17-yl acetate.(C24H32O4384.51 ) USP Megestrol Acetate Related Compound H RS 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4398.54 ) Gerald Hsu
Revision MEGESTROL ACETATE TABLETS PF 42(6) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate RS USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene-17-yl acetate.(C24H32O4 384.51 )USP Megestrol Acetate Related Compound H RS 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4 398.54 ) Gerald Hsu
Revision MEROPENEM PF 42(5) Pg. ONLINE
IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Acetone, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/ Water Determination <921>, Method I, Method Ia or Method I, Method Ic Ramanujam Prasad
Revision MEROPENEM FOR INJECTION PF 42(5) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities Ramanujam Prasad
Revision MESNA PF 43(1) Pg. ONLINE
IDENTIFICATION/B. Identification Tests-General, Sodium <191>, IDENTIFICATION/B., IDENTIFICATION/B, ASSAY/Procedure, IMPURITIES/Limit of Chloride, IMPURITIES/Limit of Sulfate, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying Hillary Cai
New MESNA INJECTION PF 43(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Benzyl Alcohol (if present), IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzaldehyde RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related Compound B RS Hillary Cai
New MESNA TABLETS PF 43(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197K>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related Compound B RS Hillary Cai
Revision METHOHEXITAL PF 42(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/<197S>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Gerald Hsu
Revision METHOHEXITAL SODIUM FOR INJECTION PF 42(5) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities Gerald Hsu
Revision METHOTREXATE INJECTION PF 41(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methotrexate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methotrexate Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methotrexate Related Compound E RS Feiwen Mao
Revision METHOTREXATE TABLETS PF 41(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methotrexate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methotrexate Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methotrexate Related Compound E RS Feiwen Mao
New METHYL ISOBUTYRATE PF 42(5) Pg. ONLINE Methyl Isobutyrate, Galina Holloway
Revision METHYLPREDNISOLONE ACETATE PF 41(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-acetate.C24H31FO6434.51 Gerald Hsu
Revision METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION PF 41(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-acetate.C24H31FO6434.51 Gerald Hsu
Revision MICONAZOLE PF 41(5) Pg. ONLINEADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Miconazole Related Compound C RS Clydewyn Anthony
Revision MYRISTIC ACID PF 42(5) Pg. ONLINE
IDENTIFICATION/B. Chromatographic Identity, ASSAY/Fats and Fixed Oils, Fatty Acid Composition <401>, ASSAY/Procedure, IMPURITIES/Limit of Lauric Acid and Palmitic Acid, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lauric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Palmitic Acid RS Galina Holloway
Revision NAPROXEN PF 42(4) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen
Revision NAPROXEN ORAL SUSPENSION PF 42(4) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Sujatha Ramakrishna
Revision NAPROXEN DELAYED-RELEASE TABLETS PF 42(4) Pg. ONLINE
IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Delayed-Release Dosage Forms, Method B Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen
Revision NAPROXEN SODIUM PF 42(4) Pg. ONLINE
IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen
New NEBIVOLOL TABLETS PF 41(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Hydrochloride RS Sujatha Ramakrishna
New NEBIVOLOL HYDROCHLORIDE PF 41(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C22H25F2NO4·HCl, Chemical Info/441.90, Chemical Info/2H-1-Benzopyran-2-methanol, α,α′-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro]-, hydrochloride, (αR,α′R,2R,2′S)-rel-;, Chemical Info/(1RS,1′RS)-1,1′-[(2RS,2′SR)-Bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2′-iminodiethanol hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Content of Nebivolol Related Compound C and Nebivolol Related Compound D, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound E RS Sujatha Ramakrishna
Revision NICOTINE TRANSDERMAL SYSTEM PF 42(2) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Drug Release <724>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Bitartrate Dihydrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound E RS Ravi Ravichandran
Revision NORETHINDRONE TABLETS PF 42(1) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone Related Compound B RS Ren-Hwa Yeh
Revision NORETHINDRONE ACETATE TABLETS PF 42(1) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone Related Compound B RS Ren-Hwa Yeh
Revision OLANZAPINE AND FLUOXETINE CAPSULES PF 42(5) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxetine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxetine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Olanzapine RS Gerald Hsu
Revision OXAPROZIN PF 42(4) Pg. ONLINE IMPURITIES/Organic Impurities Hillary Cai
Revision PALMITIC ACID PF 42(3) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, IDENTIFICATION/B. Acid Value, ASSAY/Procedure, IMPURITIES/Limit of Stearic Acid, Myristic Acid, and Other Related Fatty Acids, SPECIFIC TESTS/Fats and Fixed Oils, Acid Value <401>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Myristic Acid RS Galina Holloway
Revision PENTAZOCINE PF 42(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Labeling Hillary Cai
Revision PENTAZOCINE HYDROCHLORIDE PF 42(3) Pg. ONLINE
Chemical Info/Chemical Structure, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A., IDENTIFICATION/B. Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities Hillary Cai
Revision PRALIDOXIME CHLORIDE PF 42(6) Pg. ONLINE
Chemical Info/Pyridinium, 2-[(hydroxyimino)methyl]-1-methyl-, chloride (E)-;, Chemical Info/(E)-2-Formyl-1-methylpyridinium chloride oxime, Chemical Info/Chemical Name 14018-50-9 Unspecified isomerChemical Info/CAS, IDENTIFICATION/Infrared Absorption <197M>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Elena Gonikberg
Revision PRALIDOXIME CHLORIDE FOR INJECTION PF 42(6) Pg. ONLINEIDENTIFICATION/Infrared Absorption <197M>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Completeness of Solution <641> Elena Gonikberg
New PRASUGREL HYDROCHLORIDE PF 43(1) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C20H20FNO3S·HCl, Chemical Info/409.90, Chemical Info/Ethanone, 2-[2-(acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)-, hydrochloride;, Chemical Info/5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities 1, IMPURITIES/Organic Impurities 2, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prasugrel Hydrochloride RS Donald Min
Revision PREDNISONE PF 42(2) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cortisone RS Ren-Hwa Yeh
Revision PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES PF 42(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Promethazine Related Compound B RS Ren-Hwa Yeh
New RALTEGRAVIR TABLETS PF 42(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Raltegravir Potassium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Raltegravir Related Compound E RS Shankari Shivaprasad
New RALTEGRAVIR CHEWABLE TABLETS PF 42(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Raltegravir Potassium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Raltegravir Related Compound E RS Shankari Shivaprasad
Revision RESERPINE PF 42(6) Pg. ONLINEIDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min
Revision RESERPINE TABLETS PF 42(6) Pg. ONLINEIDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Other Alkaloids Donald Min
New ROPIVACAINE PF 43(1) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C17H26N2O, Chemical Info/274.40, Chemical Info/(S)-(-)-1-Propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide;, Chemical Info/(S)-(-)-1-Propyl-2′,6′-pipecoloxylidide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ropivacaine Related Compound A, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Color, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine Related Compound B RS Ren-Hwa Yeh
Revision SALICYLIC ACID TOPICAL FOAM PF 41(2) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound B RS Sujatha Ramakrishna
Revision SCOPOLAMINE HYDROBROMIDE PF 42(3) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norscopolamine RS Feiwen Mao
New SODIUM LAUROYL SARCOSINATE PF 42(2) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/Glycine, N-methyl-N-(1-oxododecyl)-, sodium salt;, Chemical Info/Sodium N-dodecanoyl-N-methylglycinate;, Chemical Info/Sodium N-lauroyl-N-methylglycinate;, Chemical Info/Sodium [dodecanoyl(methyl)amino]acetate, Chemical Info/C15H28NNaO3, Chemical Info/293.38, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B. Chromatographic Identity, IDENTIFICATION/C. Presence of Sodium, ASSAY/Procedure, IMPURITIES/Limit of Sodium Decanoyl Sarcosinate and Sodium Myristoyl Sarcosinate, IMPURITIES/Limit of Sodium Sarcosinate, IMPURITIES/Limit of Sodium Laurate, IMPURITIES/Limit of Sodium Chloride, IMPURITIES/Limit of Sodium Sulfate, SPECIFIC TESTS/Acidity and Alkalinity, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lauric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Decanoyl Sarcosinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Lauroyl Sarcosinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Myristoyl Sarcosinate RS Hong Wang
Revision SODIUM FLUORIDE ORAL SOLUTION PF 43(1) Pg. ONLINEIDENTIFICATION/A., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Chloride RS Michael Chang
RevisionSODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION PF 43(1) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B. Identification Tests-General <191>, Phosphate, ASSAY/Procedure 1, ASSAY/2, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Chloride RS Michael Chang
Revision SPIRONOLACTONE PF 42(1) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Epimer Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound I RS Donald Min
Revision TELMISARTAN PF 43(1) Pg. ONLINEDEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min
Revision TESTOSTERONE PF 41(4) Pg. ONLINE
IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Exemestane Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound I RS Ren-Hwa Yeh
New TESTOSTERONE TOPICAL GEL PF 41(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Viscosity-Rotational Methods <912>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound C RS Ren-Hwa Yeh
New TRANEXAMIC ACID INJECTION PF 42(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tranexamic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tranexamic Acid Related Compound C RS Sujatha Ramakrishna
Revision TRANYLCYPROMINE TABLETS PF 42(4) Pg. ONLINEIDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Sridevi Ramachandran
Revision TRETINOIN CREAM PF 41(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isotretinoin RS Feiwen Mao
Revision TRETINOIN GEL PF 42(1) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isotretinoin RS Feiwen Mao
Revision TRIAMTERENE PF 42(6) Pg. ONLINE
Chemical Info/Chemical Name 6-Phenylpteridine-2,4,7-triamine, IDENTIFICATION/Infrared Absorption <197M>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of 2,4,6-Triamino-5-nitrosopyrimidine, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamterene Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamterene Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamterene Related Compound C RS Donald Min
Revision TRIHEXYPHENIDYL HYDROCHLORIDE ORAL SOLUTION PF 42(5) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Sridevi Ramachandran
Revision TROPICAMIDE OPHTHALMIC SOLUTION PF 42(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tropicamide Related Compound A RS N-(Pyridin-4-ylmethyl)ethanamine.C8H12N2 136.19, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Tropicamide Related Compound B RS N-Ethyl-2-phenyl-N-(pyridin-4-ylmethyl)acrylamide.C17H18N2O 266.34, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tropicamide Related Compound C RS 3-Hydroxy-2-phenylpropionic acid.C9H10O3 166.17, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tropicamide Related Compound D RS 2-Phenylacetic acid.C8H8O2 136.15 Ramanujam Prasad
New UNDECANOIC ACID PF 42(4) Pg. ONLINE Undecanoic Acid Hong Wang
Revision WHITE WAX PF 42(2) Pg. ONLINE
Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F> or <197A>, IDENTIFICATION/B. Ultraviolet Absorption, SPECIFIC TESTS/Saponification Cloud Test, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class II, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Ester Value, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang
Revision YELLOW WAX PF 42(2) Pg. ONLINE
Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F> or <197A>, IDENTIFICATION/B. Ultraviolet Absorption, SPECIFIC TESTS/Saponification Cloud Test, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class II, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Ester Value, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang
Revision ZIDOVUDINE PF 43(1) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Limit of Triphenylmethanol and Other Impurities, IMPURITIES/Limit of Zidovudine Related Compounds B and C, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Triphenylmethanol, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triphenylmethanol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Zidovudine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Zidovudine Related Compound C RS Thymine.C5H6N2O2126.12 Shankari Shivaprasad
Revision ZIDOVUDINE ORAL SOLUTION PF 43(1) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Zidovudine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Zidovudine Related Compound C RS Shankari Shivaprasad
New ZINC SULFATE COMPOUNDED INJECTION PF 41(2) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Particulate Matter in Injections <788>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Zinc Sulfate RS Jeanne Sun
Revision ZIPRASIDONE HYDROCHLORIDE PF 42(1) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K> <197>, ASSAY/Procedure, IMPURITIES/Limit of Early-Eluting Impurities, IMPURITIES/Limit of Late-Eluting Impurities, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ziprasidone Related Compound F RS Sridevi Ramachandran
