General Chapter

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Admissions USP 30 Top Previous Next Admissions USP 30 Articles Admitted to USP 30 by Supplement First Supplement (April 1, 2006) GENERAL CHAPTERS 2030 Supplemental Information for Articles of Botanical Origin USP MONOGRAPHS Aprotinin Fluvo Aprotinin Injection Gabap Citalopram Hydrobromide Glybu Cladribine Ritona Fenofibrate Pure S Second Supplement (August 1, 2006) GENERAL CHAPTERS 62 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms 11 to Nons 1072 Disinfectants and Antiseptics 11 1092 The Dissolution Procedure: Development and Validation 12 Meth DIETARY SUPPLEMENTS American Ginseng Capsules USP MONOGRAPHS Benazepril Hydrochloride On Citalopram Tablets Pam Magnesium Carbonate, Citric Acid, and Potassium Citrate for Oral Solution Pam Pre Nefazodone Hydrochloride Tyl

Transcript of General Chapter

Page 1: General Chapter

Admissions USP 30 Top Previous Next

Admissions USP 30

Articles Admitted to USP 30 by Supplement

First Supplement (April 1, 2006)

GENERAL CHAPTERS

2030 Supplemental Information for Articles of Botanical Origin

USP MONOGRAPHS Aprotinin Fluvoxamine Maleate Tablets

Aprotinin Injection Gabapentin

Citalopram Hydrobromide Glyburide and Metformin Hydrochloride Tablets

Cladribine Ritonavir

Fenofibrate Pure Steam

Second Supplement (August 1, 2006)

GENERAL CHAPTERS

62 Microbiological Examination of Nonsterile Products: Tests

for Specified Microorganisms1112 Application of Water Activity Determination

toNonsterile Pharmaceutical Products

1072 Disinfectants and Antiseptics 1117 Microbiological Best Laboratory Practices

1092 The Dissolution Procedure: Development and Validation 1223 Validation of Alternative MicrobiologicalMethods

DIETARY SUPPLEMENTS American Ginseng Capsules USP MONOGRAPHS Benazepril Hydrochloride Ondansetron Orally Disintegrating Tablets

Citalopram Tablets Pamidronate Disodium

Magnesium Carbonate, Citric Acid, and Potassium Citratefor Oral Solution

Pamidronate Disodium for Injection

Prednicarbate

Nefazodone Hydrochloride Tylosin Tartrate

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Changes in Official Titles

The following title changes are official July 1, 2007

New Title Former Title

467 Residual Solvents 467 Organic Volatile Impurities

Calamine Topical Suspension Calamine Lotion

Phenolated Calamine Topical Suspension Phenolated Calamine Lotion

Resorcinol and Sulfur Topical Suspension Resorcinol and Sulfur Lotion

Selenium Sulfide Topical Suspension Selenium Sulfide Lotion

Zinc Sulfide Topical Suspension White Lotion

The following title changes are official August 1, 2007

New Title Former Title

61 Microbiological Examination ofNonsterile Products:Microbial Enumeration Tests

61 Microbial Limit Tests

62 Microbiological Examination ofNonsterile Products:Tests for Specified Microorganisms

1111 Microbiological Examination ofNonsterileProducts: Acceptance Criteria forPharmaceutical Preparationsand Substances for Pharmaceutical Use

1111 Microbiological Attributes of Nonsterile PharmaceuticalProducts

Revisions Appearing in USP 30 That Were Not Included in USP 29 Including Supplements

[NOTE—The articles included in this list are noted in the book with the following symbols USP30. This applies to new articles as well as sections of existingitems that have been revised.]

New Articles Appearing inUSP 30

USP GENERAL NOTICES

Tests and Assays

DIETARY SUPPLEMENT MONOGRAPHS

Powdered Ginkgo Extract

Ginkgo Capsules

Ginkgo Tablets

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Valerian

Powdered Valerian

USP MONOGRAPHS

Benazepril Hydrochloride Tablets

Calcitriol

Calcitriol Injection

Diclofenac Potassium

Diclofenac Potassium Tablets

Oxybutynin Chloride Extended-Release Tablets

Pancuronium Bromide

Senna Pods

Tizanidine Tablets

Valsartan

Valsartan and Hydrochlorothiazide Tablets

Revisions Appearing inUSP 30

GENERAL CHAPTERS

11 USP Reference Standards

231 Heavy Metals

621 Chromatography

2040 Disintegration and Dissolution of Dietary Supplements

DIETARY SUPPLEMENT MONOGRAPHS

Ginger

Powdered Ginger

Ginger Capsules

Ginger Tincture

Ginkgo

Valerian

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Powdered Valerian

USP MONOGRAPHS

Acetaminophen Extended-Release Tablets

Tablets Containing at Least Three of the Following—Acetaminophen and Salts of Chlorpheniramine, Dextromethorphan, and Pseudoephedrine

Amitriptyline Hydrochloride

Amoxicillin Tablets

Amoxicillin Capsules

Benzonatate Capsules

Bromocriptine Mesylate Capsules

Calcium Lactate

Calcium Lactate Tablets

Calcium Pantothenate

Carbamazepine

Cefonicid for Injection

Ceftazidime

Ceftazidime Injection

Ceftazidime for Injection

Chlorthalidone

Cimetidine Tablets

Cladribine

Clopidogrel Bisulfate

Clopidogrel Tablets

Clotrimazole Lozenges

Diphtheria Toxin for Schick Test

Etidronate Disodium

Felodipine Extended-Release Tablets

Fluoxetine Delayed-Release Capsules

Fluvastatin Sodium

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Fluvastatin Capsules

Gemcitabine Hydrochloride

Gemcitabine for Injection

Hepatitis B Virus Vaccine Inactivated

Hydroxyzine Hydrochloride

Sodium Iodide I 123 Capsules

Sodium Iodide I 123 Solution

Sodium Iodide I 131 Solution

Iodoform

Ivermectin

Lindane

Lovastatin

Mangafodipir Trisodium

Miconazole Nitrate Cream

Mirtazapine

Morphine Sulfate Extended-Release Capsules

Naphazoline Hydrochloride

Naproxen Delayed-Release Tablets

Narasin Granular

Narasin Premix

Nifedipine Extended-Release Tablets

Ondansetron Hydrochloride

Ondansetron Oral Solution

Orphenadrine Citrate Injection

Oxaprozin

Oxaprozin Tablets

Paricalcitol

Pseudoephedrine Sulfate

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Rubella and Mumps Virus Vaccine Live

Schick Test Control

Senna

Sennosides

Simvastatin

Sodium Chloride

Talc

Temazepam

Thalidomide

Thimerosal

Tizanidine Hydrochloride

Sterile Water for Inhalation

Sterile Water for Injection

Sterile Water for Irrigation

Sterile Purified Water

Water for Hemodialysis

Zidovudine Tablets

Zinc Sulfate Tablets

Articles Included in USP 29 but Not Included in USP 30

Fexofenadine Hydrochloride

Fexofenadine Hydrochloride Capsules

Admissions NF

Articles Admitted to NF 25 by Supplement

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First Supplement (April 1, 2006)

Tagatose

Second Supplement (August 1, 2006)

Diisopropanolamine Maltitol Potassium Alginate

Revisions Appearing in NF 25 That Were Not Included in NF 24 Including Supplements

[NOTE—The articles included in this list are noted in the book with the following symbols NF25. This applies to new articles as well as sections of existing

items that have been revised.]

New Monographs Appearing in NF 25

Canola Oil

Revisions Appearing in NF 25

Acetyltributyl Citrate Acetyltriethyl Citrate Calcium Silicate Cellacefate Ethylcellulose Aqueous Dispersion Glyceryl Monostearate Polacrilin Potassium Polyoxyl 35 Castor Oil Tributyl Citrate Triethyl Citrate