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Compendial Deferrals for USP40-NF35 2S

Category Monograph Title Monograph Section Scientific Liaison

Revision USP AND NF EXCIPIENTS, LISTED BY CATEGORY PF 42(2) Pg. ONLINE

{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 DESCRIPTION AND SOLUBILITY PF 42(2) Pg. ONLINE

Sodium Lauroyl Sarcosinate, Carglumic Acid, Brimonidine Tartrate, Iloperidone, Glyceryl Tricaprylate, Oxiconazole Nitrate, Raltegravir Potassium, Acamprosate Calcium, Frovatriptan Succinate, Methylnaltrexone Bromide, Nebivolol Hydrochloride, Solifenacin Succinate Hong Wang

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 <197> SPECTROPHOTOMETRIC IDENTIFICATION TESTS PF 42(5) Pg. ONLINE

Title, Introduction, INFRARED ABSORPTION, ULTRAVIOLET ABSORPTION, INTRODUCTION AND SCOPE, IDENTIFICATION METHODOLOGY, INFRARED SPECTROSCOPY, NEAR-INFRARED AND RAMAN SPECTROSCOPY, ULTRAVIOLET-VISIBLE SPECTROSCOPY, X-RAY POWDER DIFFRACTION SPECTROSCOPY, EQUIVALENT/ALTERNATIVE TESTS Edmond Biba

New<321> DRUG PRODUCT ASSAY TESTS - ORGANIC CHEMICAL MEDICINES PF 41(1) Pg. ONLINE

Title, INTRODUCTION/Paragraph Text, ASSAY/Procedure 1, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Sujatha Ramakrishna

New <327> DRUG PRODUCT IMPURITIES TESTS PF 41(1) Pg. ONLINE

Title, INTRODUCTION/Introduction, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/Solution A, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/Solution B, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/Mobile phase, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/Diluent, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/System suitability solution A, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/System suitability solution B, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/Standard solution, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/Sample solution, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/Chromatographic system, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/System suitability, IMPURITIES/Salicylic Acid in Aspirin-Containing Drug Products/Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Sujatha Ramakrishna

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


Revision<476> ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 41(3) Pg. ONLINE

Title, INTRODUCTION, IDENTIFICATION OF IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS, ANALYTICAL PROCEDURES FOR IMPURITIES AND DEGRADATION PRODUCTS, REPORTING IMPURITIES AND DEGRADATION PRODUCTS, SETTING ACCEPTANCE CRITERIA FOR IMPURITIES AND DEGRADATION PRODUCTS, QUALIFICATION OF IMPURITIES AND DEGRADATION PRODUCTS, IDENTIFICATION OF IMPURITIES AND DEGRADATION PRODUCTS Antonio Hernandez‐Cardoso

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 <661.1> PLASTIC MATERIALS OF CONSTRUCTION PF 42(4) Pg. ONLINEINTRO/Introduction, INTRO/Scope, INTRO/Specifications, INTRO/Test Methods, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Desmond Hunt

Revision<661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE PF 42(4) Pg. ONLINE SCOPE, TEST METHODS, FUNCTIONALITY Desmond Hunt

Revision <785> OSMOLALITY AND OSMOLARITY PF 42(4) Pg. ONLINEINTRODUCTION, OSMOTIC PRESSURE, OSMOLARITY, MEASUREMENT OF OSMOLALITY Margareth Marques

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

Revision <857> ULTRAVIOLET-VISIBLE SPECTROSCOPY PF 42(4) Pg. ONLINEINTRODUCTION, QUALIFICATION OF UV-VIS SPECTROPHOTOMETERS, VALIDATION AND VERIFICATION Margareth Marques

New <858> RAMAN SPECTROSCOPY PF 42(2) Pg. ONLINEIntroduction, QUALIFICATION OF RAMAN SPECTROMETERS, VALIDATION AND VERIFICATION, Title, Introduction, PROCEDURE, VERIFICATION Kahkashan Zaidi

New<909> UNIFORMITY OF DOSE FROM ORAL SUSPENSIONS IN MULTIPLE-UNIT CONTAINERS PF 40(4) Pg. ONLINE Title, PURPOSE, PROCEDURE, ACCEPTANCE CRITERIA William Brown

New<1079.1> STORAGE AND TRANSPORTATION OF INVESTIGATIONAL DRUG PRODUCTS PF 42(4) Pg. ONLINE

Title, INTRODUCTION, SCOPE, KEY FACTORS FOR IDP DISTRIBUTION, IDP ENVIRONMENTAL CONDITIONS, ASSESSING RISK EARLY IN THE DISTRIBUTION PROCESS, GLOSSARY Desmond Hunt

Revision<1086> IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 41(3) Pg. ONLINE

INTRODUCTION, DRUG SUBSTANCE, DRUG PRODUCT, DEFINITIONS, INTRODUCTION, ORGANIC IMPURITIES IN DRUG SUBSTANCES, ORGANIC IMPURITIES IN DRUG PRODUCTS, ORGANIC IMPURITIES DECISION TREE, APPENDIX 1: DEFINITIONS, APPENDIX 2: ADDITIONAL SOURCES OF INFORMATION AND GUIDANCE Antonio Hernandez‐Cardoso

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 <1210> STATISTICAL TOOLS FOR PROCEDURE VALIDATION PF 42(5) Pg. ONLINE

Title, 1. INTRODUCTION, 2. PRE-VALIDATION PROCEDURE DEVELOPMENT, 3. ACCURACY AND PRECISION, 4. LIMITS OF DETECTION AND QUANTITATION, 5. CONCLUDING REMARKS, REFERENCES Steven Walfish

Revision<1211> STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES PF 42(5) Pg. ONLINE INTRODUCTION, METHODS OF STERILIZATION, STERILITY TESTING OF LOTS Radhakrishna Tirumalai

Revision<1857> ULTRAVIOLET-VISIBLE SPECTROSCOPY - THEORY AND PRACTICE PF 42(4) Pg. ONLINE ANALYTICAL CONSIDERATIONS Margareth Marques


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 TABLETS PF 42(3) Pg. ONLINE

IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure, IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Aminophenol RS 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 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 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 AMINOBENZOATE SODIUM PF 41(2) Pg. ONLINE

Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Chloride and Sulfate, Chloride <221>, IMPURITIES/Chloride and Sulfate, Sulfate <221>, IMPURITIES/Volatile Diazotizable Substances, IMPURITIES/Limit of Aniline and p-Toluidine, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Aniline RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzocaine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Nitrobenzoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP p-Toluidine RS Wei Yang

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 ASPIRIN CAPSULES PF 41(1) Pg. ONLINE

IDENTIFICATION/A. Procedure, IDENTIFICATION/A., ASSAY/Procedure, ASSAY/Drug Product Assay Tests-Organic Chemical Medicines, Procedure 1 <321>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Free Salicylic Acid, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxylamine Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pseudoephedrine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid RS Hillary Cai

New ATORVASTATIN CALCIUM TABLETS PF 42(1) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY, ASSAY/Procedure, PERFORMANCE TESTS, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Atorvastatin Calcium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Atorvastatin Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Atorvastatin Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Atorvastatin Related Compound H RS Sujatha Ramakrishna

Revision ATROPINE SULFATE INJECTION PF 42(4) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Heather Joyce

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

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


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 BIMATOPROST PF 42(4) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C25H37NO4, Chemical Info/415.57, Chemical Info/5-Heptenamide, 7-[3,5-dihydroxy-2-(3-hydroxy-5-phenylpent-1-en-1-yl)cyclopentyl]-N-ethyl-, [1R-1[α(Z),2β(1E,3S*)3α,5α]]-;, Chemical Info/(Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(S,E)-3-hydroxy-5-phenylpent-1-en-1-yl]cyclopentyl]-N-ethylhept-5-enamide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Water Determination <921>, Method 1, Method 1c, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bimatoprost RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bimatoprost Related Compound A RS (E)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(S,E)-3-hydroxy-5-phenylpent-1-en-1-yl]cyclopentyl]-N-ethylhept-5-enamide; trans-bimatoprost.C25H37NO4 415.57 Ramanujam Prasad

New BIMATOPROST OPHTHALMIC SOLUTION PF 42(4) 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>, Osmolality, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bimatoprost RS Ramanujam Prasad

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 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

Revision BROMPHENIRAMINE MALEATE ORAL SOLUTION PF 41(1) Pg. ONLINE

IDENTIFICATION/Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Alcohol Determination, Method I <611>, PERFORMANCE TESTS/Deliverable Volume <698>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxylamine Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pseudoephedrine Hydrochloride RS Domenick Vicchio

Revision BROMPHENIRAMINE MALEATE TABLETS PF 41(1) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxylamine Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pseudoephedrine Hydrochloride RS Domenick Vicchio


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

New BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS PF 42(3) 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 Buprenorphine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naloxone RS Wei Yang

Revision CARBIDOPA AND LEVODOPA TABLETS PF 42(5) Pg. ONLINE

IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levodopa Related Compound B RS Heather Joyce

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

Revision CETYL ESTERS WAX PF 42(5) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, IDENTIFICATION/B. Fats and Fixed Oils <401>, Saponification Value, ASSAY/Total Fatty Esters and Cetyl Palmitate, IMPURITIES/Limit of Total Free Fatty Alcohols and Free Fatty Acids, SPECIFIC TESTS/Fats and Fixed Oils <401>, Saponification Value, ADDITIONAL REQUIREMENTS/Labeling, 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


Revision CHLORPHENIRAMINE MALEATE TABLETS PF 41(1) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, ASSAY/Drug Product Assay Tests-Organic Chemical Medicines , Procedure 1 <321>, PERFORMANCE TESTS/Dissolution <711>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxylamine Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pseudoephedrine Hydrochloride RS Domenick Vicchio

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

NewCLOMIPRAMINE COMPOUNDED ORAL SUSPENSION, VETERINARY PF 41(2) Pg. ONLINE

DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Hydrochloride RS Jeanne Sun


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 PF 42(3) Pg. ONLINE IMPURITIES/Organic Impurities Shankari Shivaprasad

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 COBAMAMIDE PF 42(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C72H100CoN18O17P, Chemical Info/1579.58, Chemical Info/5,6-Dimethylbenzimidazolyl-Co-5\'-deoxyadenosylcobamide;, Chemical Info/Adenosylcobalamin, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Hydroxocobalamin and Other Related Compounds, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cobamamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydroxocobalamin Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylcobalamin RS Huy Dinh

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 CREATINE PF 41(6) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C4H9N3O2·H2O, Chemical Info/149.15, Chemical Info/2-[Carbamimidoyl(methyl)amino]acetic acid;, Chemical Info/ Hydrate, Chemical Info/CAS, Chemical Info/C4H9N3O2, Chemical Info/131.13, Chemical Info/Anhydrous, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Chloride and Sulfate <221>, Sulfate, IMPURITIES/Related Compounds, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Creatine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Creatinine RS Huy Dinh

Revision CYPROHEPTADINE HYDROCHLORIDE ORAL SOLUTION PF 42(3) Pg. ONLINE

IDENTIFICATION/A. Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amitriptyline Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyproheptadine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyproheptadine Related Compound C RS 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

Revision DAUNORUBICIN HYDROCHLORIDE PF 40(6) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/C. Identification Tests-General, Chloride <191>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Daunorubicinone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dihydrodaunorubicin Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxorubicin Hydrochloride RS Ahalya Wise

Revision DAUNORUBICIN HYDROCHLORIDE FOR INJECTION PF 41(1) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Daunorubicinone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dihydrodaunorubicin Hydrochloride RS Ahalya Wise

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

NewDEXAMETHASONE SODIUM PHOSPHATE COMPOUNDED INJECTION PF 42(5) Pg. ONLINE

Title, 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 Dexamethasone Sodium Phosphate RS Jeanne Sun

Revision DEXCHLORPHENIRAMINE MALEATE TABLETS PF 41(2) Pg. ONLINE

IDENTIFICATION/A. Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/A., IDENTIFICATION/C., ASSAY/Procedure, ASSAY/Drug Product Assay Tests-Organic Chemical Medicines, Procedure 1 <321>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxylamine Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pseudoephedrine Hydrochloride RS Sujatha Ramakrishna

New DEXMEDETOMIDINE INJECTION PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexmedetomidine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Sujatha Ramakrishna

Revision DICLOFENAC POTASSIUM PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/ <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diclofenac Related Compound D RS Wei Yang

Revision DICLOFENAC SODIUM PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/ <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Color of Solution, SPECIFIC TESTS/Clarity of Solution, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diclofenac Related Compound D RS Wei Yang

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 DIVALPROEX SODIUM DELAYED-RELEASE TABLETS PF 42(5) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711> Heather Joyce

Revision DOXYCYCLINE FOR ORAL SUSPENSION PF 42(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxycycline Monohydrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxycycline Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methacycline Hydrochloride RS Praveen Pabba

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

New EPOETIN PF 41(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C809H1301N229O240S5, Chemical Info/18,236.06 Da (amino acid sequence), DEFINITION/Introduction, IDENTIFICATION/A. Erythropoietin Bioassays <124>, IDENTIFICATION/B. Peptide Mapping, ASSAY/ Erythropoietin Bioassays <124>, IMPURITIES/Limit of High Molecular Weight Proteins, SPECIFIC TESTS/N-Glycan Profiling, SPECIFIC TESTS/Isoform Distribution, SPECIFIC TESTS/Protein Content, SPECIFIC TESTS/Sterility Tests <71>, 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 Erythropoietin RS Kevin Carrick

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/&ape;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 EPTIFIBATIDE PF 42(4) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C35H49N11O9S2, Chemical Info/831.96, Chemical Info/N6-Amidino-N2-(3-mercaptopropionyl)-l-lysylglycyl-l-α-aspartyl-l-tryptophyl-l-prolyl-l-cysteinamide, cyclic(1-6)-disulfide, undefined stoichiometry, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. HPLC, IDENTIFICATION/B. Mass Spectrometry <736>, ASSAY/Procedure, ??UNKNOWN??/Procedure 1: Eptifibatide-Related Impurities, ??UNKNOWN??/Procedure 2: Limit of Trifluoroacetic Acid (TFA) <503.1>, OTHER COMPONENTS/Acetic Acid in Peptides <503>, Introduction, Method 2, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Eptifibatide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP d-Har Eptifibatide RS Elena Curti

Revision ESMOLOL HYDROCHLORIDE PF 41(2) Pg. ONLINE SPECIFIC TESTS/pH <791> Sujatha Ramakrishna

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

Revision ETHYL ACETATE PF 42(5) Pg. ONLINE

DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Limit of Methyl Compounds, IMPURITIES/Chromatographic Purity, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethyl Isobutyl Ether RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Ethyl Ketone RS Galina Holloway

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

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

Revision HARD GELATIN CAPSULE SHELL PF 41(6) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Disintegration <701>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Margareth Marques


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

Revision HYDROXYZINE PAMOATE PF 42(1) Pg. ONLINE

IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Chlorobenzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydroxyzine Related Compound A RS Heather Joyce

Revision HYDROXYZINE PAMOATE CAPSULES PF 42(1) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Chlorobenzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydroxyzine Related Compound A RS Heather Joyce

New HYPROMELLOSE CAPSULE SHELL PF 42(4) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Disintegration <701>, SPECIFIC TESTS/Microbial Enumeration Tests <61>, ADDITIONAL REQUIREMENTS/Packaging and Storage Margareth Marques


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

Revision INDAPAMIDE PF 41(2) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Chromatographic Purity, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Indapamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Indapamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Indapamide Related Compound C RS Sujatha Ramakrishna

Revision INDAPAMIDE TABLETS PF 41(2) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Indapamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Indapamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Indapamide Related Compound C RS Sujatha Ramakrishna

Revision INDOMETHACIN CAPSULES PF 42(5) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Indomethacin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Indomethacin Related Compound B RS Wei Yang

Revision DILUTED ISOSORBIDE DINITRATE PF 42(5) Pg. ONLINEIDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities Sujatha Ramakrishna

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 LiRevision L102 PF 42(4) Pg. ONLINE L102 Sujatha RamakrishnaNew 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-FREE FATTY ACIDS PF 42(4) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., 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>, Fatty Acid Composition, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Conjugated Linoleic Acids-Free Fatty Acids RS Huy Dinh

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 LITHIUM CARBONATE PF 41(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Calcium, IMPURITIES/Sodium, IMPURITIES/Calcium and Sodium, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Ren‐Hwa Yeh

Revision LITHIUM HYDROXIDE PF 42(5) Pg. ONLINEIDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Calcium, IMPURITIES/Carbonate, SPECIFIC TESTS/Lithium Content Ren‐Hwa Yeh

Revision MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION PF 41(3) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Megestrol Acetate RS Gerald Hsu

Revision MEDROXYPROGESTERONE ACETATE TABLETS PF 41(3) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Megestrol Acetate RS Gerald Hsu

Revision MEFENAMIC ACID PF 42(5) Pg. ONLINE IDENTIFICATION/<197K>, ASSAY/Procedure, IMPURITIES/Organic Impurities Hillary Cai


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 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 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 PF 41(2) Pg. ONLINE

IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/C., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound D RS Gerald Hsu

Revision METHYLPREDNISOLONE TABLETS PF 41(2) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prednisone RS Gerald Hsu

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 METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS PF 42(5) Pg. ONLINE

IDENTIFICATION/C., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metoprolol Related Compound A RS Donald Min

Revision METOPROLOL TARTRATE INJECTION PF 42(1) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metoprolol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metoprolol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metoprolol Related Compound C RS Donald Min

Revision MICONAZOLE PF 41(5) Pg. ONLINEADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Miconazole Related Compound C RS Clydewyn Anthony

New MORPHINE SULFATE COMPOUNDED INJECTION PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, Test for Sterility of the Product to be Examined, Membrane Filtration, 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 Morphine Sulfate RS Jeanne Sun

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 Donald Min

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 Donald Min

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


New NILUTAMIDE PF 42(2) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C12H10F3N3O4, Chemical Info/317.22, Chemical Info/2,4-Imidazolidinedione, 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-;, Chemical Info/5,5-Dimethyl-3-(α,α,α-trifluoro-4-nitro-m-tolyl)hydantoin;, Chemical Info/5,5-Dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-imidazolidine-2,4-dione, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Flutamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilutamide RS Ren‐Hwa Yeh

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 OCTYLDODECANOL PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, IDENTIFICATION/B. Fats and Fixed Oils <401>, Hydroxyl Value, ASSAY/Procedure, IMPURITIES/Organic Impurity Test 1: Limit of Related Fatty Alcohols and Alkanes, SPECIFIC TESTS/Fats and Fixed Oils <401>, Hydroxyl Value Galina Holloway

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

New OXICONAZOLE NITRATE PF 42(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C18H13Cl4N3O·HNO3, Chemical Info/ 492.14, Chemical Info/Ethanone, 1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)-, O-[(2,4-dichlorophenyl)methyl]oxime, (Z)-, mononitrate;, Chemical Info/2′,4′-Dichloro-2-imidazol-1-ylacetophenone (Z)-[O-(2,4-dichlorobenzyl)oxime], mononitrate, 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>, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxiconazole Nitrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxiconazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxiconazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxiconazole Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxiconazole Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxiconazole Related Compound E RS Shankari Shivaprasad

New PAIRED ION CHROMATOGRAPHY REAGENT PF 42(1) Pg. ONLINE Paired Ion Chromatography Reagent Sujatha Ramakrishna


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 PARALDEHYDE PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197F>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Chloride, IMPURITIES/Sulfate, IMPURITIES/Limit of Acetaldehyde, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Congealing Temperature <651>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Gerald Hsu

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 PENTAZOCINE INJECTION PF 42(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B. Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Hillary Cai

New 0.01% PHOSPHORIC ACID TS PF 42(3) Pg. ONLINE 0.01% Phosphoric Acid TS- Ramanujam Prasad

Revision PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS PF 42(4) Pg. ONLINEIDENTIFICATION/C. Infrared Absorption <197K>, PERFORMANCE TESTS/Dissolution <711> Elena Gonikberg

New POTASSIUM PHOSPHATES COMPOUNDED INJECTION PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, ASSAY/Procedure for Potassium, ASSAY/Procedure for Phosphate, 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 Dibasic Potassium Phosphate RS Jeanne Sun

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

New RALTEGRAVIR POTASSIUM PF 42(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C20H20FKN6O5, Chemical Info/482.51, Chemical Info/4-Pyrimidinecarboxamide, N-[(4-fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-, monopotassium salt;, Chemical Info/Potassium 4-[(4-fluorobenzyl)carbamoyl]-1-methyl-2-(1-methyl-1-{[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino}ethyl)-6-oxo-1,6-dihydropyrimidin-5-olate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, 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 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 LAURYL SULFATE PF 42(5) Pg. ONLINE IDENTIFICATION/C., IDENTIFICATION/D. Kevin Moore


New SODIUM BICARBONATE COMPOUNDED INJECTION PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, ASSAY/Procedure for Sodium, ASSAY/Procedure for Bicarbonate, 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 Sodium Chloride RS Jeanne Sun

New SODIUM PHOSPHATES COMPOUNDED INJECTION PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, ASSAY/Procedure for Sodium, ASSAY/Procedure for Phosphate, 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 Sodium Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dibasic Sodium Phosphate RS Jeanne Sun

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 SILVER SULFADIAZINE CREAM PF 42(1) 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 Sulfadiazine RS Praveen Pabba

Revision SULFAMETHOXAZOLE PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Selenium <291>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class I <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfamethoxazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfamethoxazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfamethoxazole Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfamethoxazole Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfanilamide RS Praveen Pabba


New TANGERINE PEEL PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Dihydroflavone Glycosides and Polymethoxylated Flavones, 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 Procedures, Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, 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, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Water Determination <921>, Method II, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Citrus reticulata Pericarp Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hesperidin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nobiletin RS Cuiying Ma

New TANGERINE PEEL DRY EXTRACT PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Dihydroflavone Glycosides and Polymethoxylated Flavones, CONTAMINANTS/Elemental Impurities-Procedures <233>, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, 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/Water Determination <921>, Method II, 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 Citrus reticulata Pericarp Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hesperidin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nobiletin RS Cuiying Ma


New TANGERINE PEEL POWDER PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Dihydroflavone Glycosides and Polymethoxylated Flavones, 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 Procedures, Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, 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, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Water Determination <921>, Method II, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Citrus reticulata Pericarp Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hesperidin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nobiletin RS Cuiying Ma

New TELMISARTAN AND AMLODIPINE 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 Amlodipine Besylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Telmisartan RS 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

Revision TRANDOLAPRIL TABLETS PF 42(5) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities Donald Min


NewTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS PF 42(4) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>: Test 1, PERFORMANCE TESTS/Dissolution <711>: Test 2, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Trandolapril Related Impurities, Procedure 1, IMPURITIES/Trandolapril Related Impurities, Procedure 2, IMPURITIES/Content of Trandolapril Related Compound E, IMPURITIES/Verapamil Hydrochloride Related Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trandolapril RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trandolapril Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trandolapril Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trandolapril Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Verapamil Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Verapamil Related Compound B RS Donald Min

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 Donald Min

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 TRIACETIN PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Specific Gravity <841>, SPECIFIC TESTS/Refractive Index <831>, SPECIFIC TESTS/Acidity Praveen Pabba

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

New UNDECANOIC ACID PF 42(4) Pg. ONLINE Undecanoic Acid Hong Wang

Revision STERILE WATER FOR INHALATION PF 41(3) Pg. ONLINESPECIFIC TESTS/Oxidizable Substances, SPECIFIC TESTS/Total Organic Carbon <643>, Sterile Water Antonio Hernandez‐Cardoso

Revision STERILE WATER FOR INJECTION PF 41(3) Pg. ONLINESPECIFIC TESTS/Oxidizable Substances, SPECIFIC TESTS/Total Organic Carbon <643>, Sterile Water Antonio Hernandez‐Cardoso

Revision STERILE WATER FOR IRRIGATION PF 41(3) Pg. ONLINESPECIFIC TESTS/Oxidizable Substances, SPECIFIC TESTS/Total Organic Carbon <643>, Sterile Water Antonio Hernandez‐Cardoso

Revision STERILE PURIFIED WATER PF 41(3) Pg. ONLINESPECIFIC TESTS/Oxidizable Substances, SPECIFIC TESTS/Total Organic Carbon <643>, Sterile Water Antonio Hernandez‐Cardoso


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

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

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