Compendial Deferrals for USP41-NF36

Category Monograph Title Monograph Section Scientific Liaison

{Emollient} Isopropyl Isostearate, {Emollient} Isostearyl Isostearate, {Emulsifying Agent} Isopropyl Isostearate, {Emulsifying Agent} Isostearyl Isostearate, {Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent}, {Emulsifying Agent} Glyceryl Tricaprylate, {Lubricant} Glyceryl Revision USP AND NF EXCIPIENTS, LISTED BY CATEGORY PF 43(1) Pg. ONLINE Tricaprylate, {Vehicle (solid carrier)} Glyceryl Tricaprylate Hong Wang Introduction, 1. INTRODUCTION, 2. GENERAL QUALITY TESTS FOR INHALATION DRUG <5> INHALATION AND NASAL DRUG PRODUCTS GENERAL INFORMATION AND PRODUCTS, 3. GENERAL QUALITY TESTS FOR NASAL DRUG PRODUCTS, 4. Revision PRODUCT QUALITY TESTS PF 43(1) Pg. ONLINE DESCRIPTION OF PRODUCT QUALITY TESTS Kahkashan Zaidi Bendamustine Hydrochloride, Isopropyl Isostearate, Isostearyl Isostearate, Ropivacaine, Bortezomib, Sodium Lauroyl Sarcosinate, Gatifloxacin, Carglumic Acid, Brimonidine Tartrate, Iloperidone, Glyceryl Tricaprylate, Oxiconazole Nitrate, Acamprosate Calcium, Frovatriptan Succinate, Nebivolol Hydrochloride, Solifenacin New DESCRIPTION AND SOLUBILITY PF 43(1) Pg. ONLINE Succinate Feiwen Mao

INTRODUCTION/Introduction, PROCEDURE/Assay, PROCEDURE/B. In Vitro Cell-Based Revision <123> GLUCAGON BIOIDENTITY TESTS PF 41(2) Pg. ONLINE Bioidentity Test, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Maura Kibbey

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, Revision <467> RESIDUAL SOLVENTS PF 41(5) Pg. ONLINE APPENDICES Horacio Pappa Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards New <509> RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE <11> Maura Kibbey

TABLE OF CONTENTS, INTRODUCTION, A. DELIVERED-DOSE UNIFORMITYDELIVERED CONTENT UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS <601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND AND SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION-INHALATION Revision POWDERS--PERFORMANCE QUALITY TESTS PF 42(6) Pg. ONLINE AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi <661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE PF 42(4) Pg. Revision ONLINE SCOPE, TEST METHODS, FUNCTIONALITY Desmond Hunt 2. QUALIFICATION OF NIR SPECTROMETERS, 3. PROCEDURE, 4. VALIDATION AND VERIFICATION, 1. INTRODUCTION, 2. QUALIFICATION OF NIR SPECTROMETERS, USP New <856> NEAR-INFRARED SPECTROSCOPY PF 42(2) Pg. ONLINE REFERENCE STANDARDS <11> Kahkashan Zaidi Introduction, QUALIFICATION OF RAMAN SPECTROMETERS, VALIDATION AND New <858> RAMAN SPECTROSCOPY PF 42(2) Pg. ONLINE VERIFICATION, Title, Introduction, PROCEDURE, VERIFICATION Kahkashan Zaidi Title, BACKGROUND, BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION, <1090> ASSESSMENT OF DRUG PRODUCT PERFORMANCE--BIOAVAILABILITY, BIOEQUIVALENCE, DISSOLUTION AND IN VITRO PRODUCT PERFORMANCE, Revision BIOEQUIVALENCE, AND DISSOLUTION PF 42(4) Pg. ONLINE BIOWAIVER, APPENDIX William Brown 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: Revision <1119> NEAR-INFRARED SPECTROSCOPY PF 41(1) Pg. ONLINE GLOSSARY Kahkashan Zaidi

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 Revision <1120> RAMAN SPECTROSCOPY PF 40(6) Pg. ONLINE VALIDATION Kahkashan Zaidi

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 New ACAMPROSATE DELAYED-RELEASE TABLETS PF 41(6) Pg. ONLINE B RS Heather Joyce

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/4-Aminophenol in Acetaminophen- Revision ACETAMINOPHEN ORAL SUSPENSION PF 42(6) Pg. ONLINE Containing Drug Products <227>, IMPURITIES/Organic Impurities Clydewyn Anthony IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, Revision ACETAMINOPHEN TABLETS PF 42(3) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure Clydewyn Anthony

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 ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN Chlorpheniramine Maleate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE ORAL SUSPENSION PF 42(4) <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP New Pg. ONLINE Reference Standards <11>/USP Phenylephrine Hydrochloride RS Clydewyn Anthony 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 ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 42(4) Pg. ONLINE Phenylephrine Related Compound F RS Clydewyn Anthony

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, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TABLETS PF ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine New 42(4) Pg. ONLINE Related Compound F RS Clydewyn Anthony

ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetazolamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Revision ACETAZOLAMIDE TABLETS PF 42(6) Pg. ONLINE Standards <11>/USP Acetazolamide Related Compound E RS Ramanujam Prasad

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 Revision ALBUMIN HUMAN PF 41(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Kevin Carrick

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 Revision ALBUTEROL TABLETS PF 41(5) Pg. ONLINE RS Mary Koleck ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Revision ALCLOMETASONE DIPROPIONATE CREAM PF 43(1) Pg. ONLINE Dipropionate RS Mary Koleck ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Revision ALCLOMETASONE DIPROPIONATE OINTMENT PF 43(1) Pg. ONLINE Dipropionate RS Mary Koleck 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 Revision ALPRAZOLAM TABLETS PF 41(6) Pg. ONLINE Compound A RS Heather Joyce ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound H Revision AMOXICILLIN FOR ORAL SUSPENSION PF 42(6) Pg. ONLINE RS Ramanujam Prasad

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 New ANNATTO SEED TOCOTRIENOLS EXTRACT PF 42(3) Pg. ONLINE Seed Tocotrienols Extract RS Huy Dinh

Revision ASHWAGANDHA ROOT PF 42(2) Pg. ONLINE COMPOSITION/Content of Withanolides, ADDITIONAL REQUIREMENTS/Labeling Anton Bzhelyansky

{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- Revision POWDERED ASHWAGANDHA ROOT PF 42(2) Pg. ONLINE Robinoside-7-O-glucoside RS Anton Bzhelyansky {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- Revision POWDERED ASHWAGANDHA ROOT EXTRACT PF 42(2) Pg. ONLINE glucoside RS Anton Bzhelyansky

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 Revision ASPIRIN PF 41(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid RS Clydewyn Anthony

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Foreign Alkaloids and Other Impurities, IMPURITIES/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Melting Range or Temperature Revision ATROPINE PF 43(1) Pg. ONLINE <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Atropine RS Heather Joyce Title, DEFINITION/Introduction, IDENTIFICATION/Nucleic Acid-Based Identification, ASSAY/Enumeration, SPECIFIC TESTS/Loss on Drying <731>, CONTAMINANTS/Yeasts, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Escherichia coli and Test for Absence of Salmonella Species, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Packaging and Storage, New BACILLUS COAGULANS PF 43(1) Pg. ONLINE ADDITIONAL REQUIREMENTS/Labeling Seong Jae Yoo

Title, DEFINITION/Introduction, IDENTIFICATION/Nucleic Acid-Based Identification, ASSAY/Enumeration, PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Disintegration, PERFORMANCE TESTS/Weight Variation <2091>, CONTAMINANTS/Yeasts, CONTAMINANTS/Coliforms, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Escherichia coli and Test for Absence of Salmonella Species, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL New BACILLUS COAGULANS CAPSULES PF 43(1) Pg. ONLINE REQUIREMENTS/Labeling Seong Jae Yoo

IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Immediate-Release Dosage Forms, Procedure Revision BACLOFEN TABLETS PF 42(5) Pg. ONLINE for a pooled sample, IMPURITIES/Organic Impurities Heather Joyce Omission BCG VACCINE PF 43(1) Pg. ONLINE Entire document Dibyendu Saha

Title, Chemical Info/Chemical Structure, Chemical Info/C16H21Cl2N3O2·HCl, Chemical Info/394.72, Chemical Info/1H-Benzimidazole-2-butanoic acid, 5-[bis(2- chloroethyl)amino]-1-methyl-, monohydrochloride;, Chemical Info/4-{5-[Bis(2- chloroethyl)amino]-1-methyl-1H-benzimidazole-2-yl}butanoic acid monohydrochloride, Chemical Info/CAS, Chemical Info/Bendamustine (free base), Chemical Info/C16H21Cl2N3O2, Chemical Info/358.26, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference New BENDAMUSTINE HYDROCHLORIDE PF 43(1) Pg. ONLINE Standards <11>/USP Bendamustine Related Compound I RS Feiwen Mao Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, PERFORMANCE TESTS/ Uniformity of Dosage Units <905>, Weight Variation, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/ Sterility Tests <71>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling <7>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference New BENDAMUSTINE HYDROCHLORIDE FOR INJECTION PF 43(1) Pg. ONLINE Standards <11>/USP Bendamustine Related Compound I RS Feiwen Mao IDENTIFICATION/Infrared Absorption <197K>, IMPURITIES/Organic Impurities, Revision BENZETHONIUM CHLORIDE PF 42(6) Pg. ONLINE SPECIFIC TESTS/Melting Range or Temperature <741> Sujatha Ramakrishna New BENZIL PF 42(4) Pg. ONLINE Benzil Hillary Cai

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 Revision BETAMETHASONE ACETATE PF 42(5) Pg. ONLINE Standards <11>/USP Dexamethasone Acetate RS Mary Koleck

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Revision BETAMETHASONE DIPROPIONATE CREAM PF 42(6) Pg. ONLINE Related Compound C RS Mary Koleck

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Revision BETAMETHASONE DIPROPIONATE LOTION PF 42(6) Pg. ONLINE Related Compound C RS Mary Koleck 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 SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTABLE Betamethasone Acetate Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Revision SUSPENSION PF 42(5) Pg. ONLINE Reference Standards <11>/USP Dexamethasone Acetate RS Mary Koleck

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 New BIVALIRUDIN PF 41(5) Pg. ONLINE Reference Standards <11>/USP Endotoxin RS Elena Curti

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, New BIVALIRUDIN FOR INJECTION PF 41(5) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Elena Curti Title, Chemical Info/Chemical Structure, Chemical Info/C19H25BN4O4, Chemical Info/384.24 (boronic acid form), Chemical Info/Boronic acid, [(1R)-3-methyl-1-[[(2S)-1- oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]-;, Chemical Info/{(R)-3- Methyl-1-[(S)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido]butyl}boronic acid;, Chemical Info/N-[(1S)-1-Benzyl-2-[[(1R)-1-(dihydroxyboranyl)-3-methylbutyl]amino]-2- oxoethyl]pyrazinecarboxamide, Chemical Info/CAS, Chemical Info/C57H69B3N12O9, Chemical Info/1098.67 (trimeric boroxine form), DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bortezomib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bortezomib Related Compound A New BORTEZOMIB PF 42(6) Pg. ONLINE RS Feiwen Mao

Title, DEFINITION/Introduction, DEFINITION/Note, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/ Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling <7>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bortezomib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bortezomib Related Compound A New BORTEZOMIB FOR INJECTION PF 42(6) Pg. ONLINE RS Feiwen Mao

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 New BRIMONIDINE TARTRATE PF 42(4) Pg. ONLINE Reference Standards <11>/USP Brimonidine Related Compound E RS Ramanujam Prasad

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 New BUDESONIDE DELAYED-RELEASE CAPSULES PF 42(5) Pg. ONLINE <11>/USP Budesonide Related Compound L RS Mary Koleck 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 Revision BUPIVACAINE HYDROCHLORIDE PF 41(3) Pg. ONLINE Reference Standards <11>/USP Ropivacaine Related Compound A RS Mary Koleck 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 Revision BUPIVACAINE HYDROCHLORIDE INJECTION PF 41(3) Pg. ONLINE RS Mary Koleck

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 Revision BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION PF 41(3) Pg. ONLINE Related Compound B RS Mary Koleck

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 Revision CARBINOXAMINE MALEATE PF 42(2) Pg. ONLINE Compound C RS Mary Koleck

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 Revision CARBINOXAMINE MALEATE TABLETS PF 42(2) Pg. ONLINE <11>/USP Carbinoxamine Related Compound B RS Mary Koleck 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 New CARGLUMIC ACID PF 41(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Pyroglutamic Acid RS Sujatha Ramakrishna

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, Revision CASTOR OIL PF 41(5) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang New CHELATING ION EXCHANGE RESIN PF 41(3) Pg. ONLINE Chelating Ion-Exchange Resin Trish Li New 2-CHLOROBENZOPHENONE PF 42(3) Pg. ONLINE 2-Chlorobenzophenone, Ramanujam Prasad

Title, Chemical Info/Chemical Structure, Chemical Info/C22H28ClNO5, Chemical Info/421.91, Chemical Info/Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, salt with 2-[4- (4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (1:1);, Chemical Info/2-Hydroxy- N,N,N-trimethylethanaminium 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Choline Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Choline Fenofibrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibrate Related Compound C New CHOLINE FENOFIBRATE PF 42(6) Pg. ONLINE RS Edith Chang 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 New CINACALCET TABLETS PF 42(4) Pg. ONLINE Compound A RS Elena Gonikberg

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- New CINACALCET HYDROCHLORIDE PF 42(4) Pg. ONLINE (Trifluoromethyl)phenyl]propan-1-ol.C10H11F3O204.19 Elena Gonikberg

Title, Chemical Info/Chemical Structure, Chemical Info/C14H25N4NaO11P2, Chemical Info/510.31, Chemical Info/Cytidine 5\'-(trihydrogen diphosphate), P\'-[2- (trimethylammonio)ethyl] ester, inner salt, monosodium salt;, Chemical Info/CDP- choline (sodium), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Chloride and Sulfate <221>, Chloride, IMPURITIES/Related Compounds, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Citicoline Sodium RS, ADDITIONAL REQUIREMENTS/USP New CITICOLINE SODIUM PF 42(6) Pg. ONLINE Reference Standards <11>/USP 5′-Cytidylic Acid RS Huy Dinh 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 Revision CLOMIPRAMINE HYDROCHLORIDE PF 42(3) Pg. ONLINE <11>/USP Clomipramine Related Compound F RS Heather Joyce

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 Revision CLOMIPRAMINE HYDROCHLORIDE CAPSULES PF 42(3) Pg. ONLINE Standards <11>/USP Clomipramine Related Compound C RS Heather Joyce IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Revision CLOTRIMAZOLE CREAM PF 42(3) Pg. ONLINE Specified Microorganisms <62> Shankari Shivaprasad

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 New COFFEE FRUIT DRY EXTRACT PF 42(2) Pg. ONLINE Extract RS Cuiying Ma Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Triglycerides, CONTAMINANTS/Limit of Zearalenone, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella species and Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coix Seed Oil Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oleic Acid RS, New COIX SEED PF 42(6) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triolein RS Cuiying Ma

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Triglycerides, CONTAMINANTS/Limit of Zearalenone, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella species and Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coix Seed Oil Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oleic Acid RS, ADDITIONAL New COIX SEED POWDER PF 42(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Triolein RS Cuiying Ma DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities: Procedure for the Sterile Powder Formulation, IMPURITIES/Organic Impurities: Procedure for the Lyophilized Formulation, IMPURITIES/Limit of Cyclophosphamide Related Compound C: Procedure for the Lyophilized Formulation, SPECIFIC TESTS/Limit of Chloride for the Lyophilized Formulation, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Revision CYCLOPHOSPHAMIDE FOR INJECTION PF 43(1) Pg. ONLINE Reference Standards <11>/USP Cyclophosphamide Related Compound D RS Feiwen Mao Revision CYCLOSPORINE PF 43(1) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Slavica Shane IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure for Where Capsules Contain Liquid, ASSAY/Procedure for Where Capsules Contain Powder, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision CYCLOSPORINE CAPSULES PF 43(1) Pg. ONLINE Cyclosporine Resolution Mixture RS Slavica Shane

IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, OTHER COMPONENTS/Content of Alcohol (where present), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision CYCLOSPORINE INJECTION PF 43(1) Pg. ONLINE <11>/USP Cyclosporine Resolution Mixture RS Slavica Shane

IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, OTHER COMPONENTS/Content of Alcohol (where present), ADDITIONAL REQUIREMENTS/USP Reference Standards Revision CYCLOSPORINE ORAL SOLUTION PF 43(1) Pg. ONLINE <11>/USP Cyclosporine Resolution Mixture RS Slavica Shane Revision CYPROHEPTADINE HYDROCHLORIDE TABLETS PF 43(1) Pg. ONLINE IMPURITIES/Organic Impurities Mary Koleck

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 New DARIFENACIN HYDROBROMIDE PF 42(2) Pg. ONLINE Identification Mixture RS Elena Gonikberg New DESCHLOROCLOTRIMAZOLE PF 42(1) Pg. ONLINE Deschloroclotrimazole Ramanujam Prasad IDENTIFICATION/B. Thin-Layer Chromatography, IDENTIFICATION/B., Revision DESOXIMETASONE PF 42(1) Pg. ONLINE ASSAY/Procedure Mary Koleck

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 Revision DEXAMETHASONE PF 42(4) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS Mary Koleck

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Related Substances, SPECIFIC TESTS/Optical Rotation <781S>, Specific Revision DEXTROSE EXCIPIENT PF 42(6) Pg. ONLINE Rotation, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Galina Holloway New 7,8-DIHYDROFOLIC ACID PF 42(5) Pg. ONLINE 7,8-Dihydrofolic Acid K. Seela

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 Revision DIPYRIDAMOLE TABLETS PF 41(3) Pg. ONLINE Related Compound F RS Sujatha Ramakrishna

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 Revision DOXYLAMINE SUCCINATE PF 42(3) Pg. ONLINE <11>/USP Carbinoxamine Related Compound C RS Richard Nguyen

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 Revision DOXYLAMINE SUCCINATE TABLETS PF 42(3) Pg. ONLINE Related Compound C RS Richard Nguyen

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Adrenalone, IMPURITIES/Limit of Norepinephrine, IMPURITIES/Enantiomeric Purity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Adrenalone Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norepinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision EPINEPHRINE PF 42(6) Pg. ONLINE <11>/USP Racepinephrine Hydrochloride RS Sujatha Ramakrishna Title, Chemical Info/Chemical Structure, Chemical Info/C1982H3054N560O618S28, Chemical Info/INS: (The chemical formula includes the γ-carboxylations and modification of D (Asp) in position 63, and does not include the glycosylations.), Chemical Info/≊50,000 (The molecular weight includes the glycosylation.), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Peptide Mapping, ASSAY/Concentration of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Gla-Domainless Eptacog Alfa (γ-Carboxylation), IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, IMPURITIES/Non-Activated Factor VII (Single Chain), SPECIFIC TESTS/Glycan Analysis, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New EPTACOG ALFA ACTIVATED PF 41(3) Pg. ONLINE Coagulation Factor VIIa for Bioassay RS Kevin Carrick

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 New EPTACOG ALFA ACTIVATED FOR INJECTION PF 41(3) Pg. ONLINE Standards <11>/USP Coagulation Factor VIIa for Bioassay RS Kevin Carrick

Title, DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP New ESTRIOL COMPOUNDED VAGINAL CREAM PF 42(5) Pg. ONLINE Reference Standards <11>/USP Estriol RS Jeanne Sun Title, Chemical Info/Chemical Structure, Chemical Info/C53H83NO14, Chemical Info/958.22, Chemical Info/(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy- 12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]- 19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4- azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone;, Chemical Info/(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)- 9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3- [(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21- dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1- c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Alcohol, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Sirolimus, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Organisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Everolimus RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Everolimus System Suitability Mixture RS, ADDITIONAL New EVEROLIMUS PF 42(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Sirolimus RS Morgan Puderbaugh

Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference New FENOFIBRIC ACID DELAYED-RELEASE CAPSULES PF 42(6) Pg. ONLINE Standards <11>/USP Fenofibric Acid RS Edith Chang

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> <197>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC Revision FLECAINIDE ACETATE PF 42(2) Pg. ONLINE TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Clarity of Solution Sujatha Ramakrishna IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Organic Impurities, ADDITIONAL Revision FLECAINIDE ACETATE TABLETS PF 42(2) Pg. ONLINE REQUIREMENTS/Packaging and Storage Sujatha Ramakrishna

IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL Revision FLUDROCORTISONE ACETATE TABLETS PF 43(1) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone RS Gerald Hsu 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 New FLUVASTATIN EXTENDED-RELEASE TABLETS PF 42(4) Pg. ONLINE System Suitability RS Sujatha Ramakrishna IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Test 2, ADDITIONAL Revision FLUVOXAMINE MALEATE TABLETS PF 42(5) Pg. ONLINE REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Heather Joyce

ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/USP Revision FONDAPARINUX SODIUM PF 42(5) Pg. ONLINE Reference Standards <11>/USP Fondaparinux Sodium System Suitability Mixture B RS Kevin Carrick

IDENTIFICATION/B. Identification Tests-General <191>, Chloride, ASSAY/Procedure, Revision FONDAPARINUX SODIUM INJECTION PF 42(5) Pg. ONLINE IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85> Kevin Carrick 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 New FROVATRIPTAN TABLETS PF 41(5) Pg. ONLINE Related Compound A RS Heather Joyce

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 New FROVATRIPTAN SUCCINATE PF 41(5) Pg. ONLINE Standards <11>/USP Frovatriptan Succinate RS Heather Joyce

Title, Chemical Info/Chemical Structure, Chemical Info/C19H22FN3O4, Chemical Info/375.40, Chemical Info/Quinoline-3-carboxylic acid, 1-cyclopropyl-6-fluoro-8- methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-1,4-dihydro, (±);, Chemical Info/(±)-1- Cyclopropyl-6-fluoro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-1,4-dihydroquinoline- 3-carboxylic acid, Chemical Info/CAS, Chemical Info/Sesquihydrate, Chemical Info/402.42, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference New GATIFLOXACIN PF 42(6) Pg. ONLINE Standards <11>/USP Gatifloxacin Related Compound E RS Shankari Shivaprasad Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Osmolality and Osmolarity <785>, SPECIFIC TESTS/Particulate Matter in Ophthalmic Solutions <789>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gatifloxacin New GATIFLOXACIN OPHTHALMIC SOLUTION PF 42(6) Pg. ONLINE Related Compound D RS Shankari Shivaprasad

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 New GLYCERYL TRICAPRYLATE PF 42(5) Pg. ONLINE Standards <11>/USP Methyl Laurate RS Hong Wang

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 New GUANIDINE HYDROCHLORIDE PF 42(4) Pg. ONLINE <11>/USP Guanidine Hydrochloride RS Galina Holloway ASSAY/Procedure, IMPURITIES/Limit of 4-Chlorobenzophenone, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydroxyzine Related Compound A RS 1-[(4- Revision HYDROXYZINE HYDROCHLORIDE INJECTION PF 41(1) Pg. ONLINE Chlorophenyl)phenylmethyl]piperazine.C17H19ClN2286.80 Heather Joyce 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 New ILOPERIDONE PF 42(1) Pg. ONLINE RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Vanillin RS Heather Joyce

Title, Chemical Info/INS: Isooctadecanoic acid, 1-methylethyl ester contains mainly isomers of isopropyl branched stearates., Chemical Info/Chemical Structure, Chemical Info/C21H42O2, Chemical Info/326.56, Chemical Info/Isooctadecanoic acid, 1- methylethyl ester, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or <197F>, IDENTIFICATION/B., ASSAY/Content of Isopropyl Fatty Esters, IMPURITIES/Residue on Ignition <281>, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Hydroxyl Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Iodine Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Saponification Value, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isopropyl Isostearate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isopropyl Myristate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isopropyl New ISOPROPYL ISOSTEARATE PF 43(1) Pg. ONLINE Palmitate RS Hong Wang

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Revision ISOSORBIDE DINITRATE TABLETS PF 42(5) Pg. ONLINE 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 Li New L##_EPTACOG alfa, Dionex DNAPac PA100 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex DNAPac PA100) Trish Li New L107 PF 40(6) Pg. ONLINE L## (Rosuvastatin Calcium, CHIRALCEL OJ-RH) Sujatha Ramakrishna

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 Revision LEUCOVORIN CALCIUM PF 42(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Folic Acid RS Feiwen Mao 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 New LEUCOVORIN CALCIUM FOR INJECTION PF 42(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Leucovorin Calcium RS Feiwen Mao IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Limit of Ethynyl Group, Revision LEVONORGESTREL PF 41(5) Pg. ONLINE IMPURITIES/Organic Impurities Gerald Hsu

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 New CONJUGATED LINOLEIC ACIDS-TRIGLYCERIDES PF 42(4) Pg. ONLINE Standards <11>/USP Conjugated Linoleic Acids-Triglycerides RS Huy Dinh

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 Revision MEFENAMIC ACID CAPSULES PF 42(5) Pg. ONLINE RS Hillary Cai

DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate RSUSP Megestrol Acetate Related Compound C RS 6,13aβ-Dimethyl-3,17-dioxo- 13(17)a-homoandrosta-4,6-diene-13a-yl acetate.(C24H34O4386.52 ) USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene-17-yl acetate.(C24H32O4384.51 ) USP Megestrol Acetate Related Compound H RS Revision MEGESTROL ACETATE PF 42(6) Pg. ONLINE 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4398.54 ) Gerald Hsu

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate RS USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene- 17-yl acetate.(C24H32O4 384.51 )USP Megestrol Acetate Related Compound H RS Revision MEGESTROL ACETATE TABLETS PF 42(6) Pg. ONLINE 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4 398.54 ) Gerald Hsu 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 Revision MEROPENEM PF 42(5) Pg. ONLINE Method I, Method Ic Ramanujam Prasad Revision MEROPENEM FOR INJECTION PF 42(5) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities Ramanujam Prasad IDENTIFICATION/B. Identification Tests-General, Sodium <191>, IDENTIFICATION/B., IDENTIFICATION/B, ASSAY/Procedure, IMPURITIES/Limit of Chloride, IMPURITIES/Limit Revision MESNA PF 43(1) Pg. ONLINE of Sulfate, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying Hillary Cai

Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Benzyl Alcohol (if present), IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzaldehyde RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related New MESNA INJECTION PF 43(1) Pg. ONLINE Compound B RS Hillary Cai

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197K>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mesna Related New MESNA TABLETS PF 43(1) Pg. ONLINE Compound B RS Hillary Cai

DEFINITION/Introduction, IDENTIFICATION/<197S>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Revision METHOHEXITAL PF 42(5) Pg. ONLINE Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Gerald Hsu IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Revision METHOHEXITAL SODIUM FOR INJECTION PF 42(5) Pg. ONLINE IMPURITIES/Organic Impurities Gerald Hsu

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 Revision METHOTREXATE INJECTION PF 41(4) Pg. ONLINE Related Compound E RS Feiwen Mao

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 Revision METHOTREXATE TABLETS PF 41(4) Pg. ONLINE Related Compound E RS Feiwen Mao New METHYL ISOBUTYRATE PF 42(5) Pg. ONLINE Methyl Isobutyrate, Galina Holloway 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- Revision METHYLPREDNISOLONE ACETATE PF 41(6) Pg. ONLINE 16α-methylpregna-1,4-diene-3,20-dione 21-acetate.C24H31FO6434.51 Gerald Hsu

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- Revision METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION PF 41(6) Pg. ONLINE acetate.C24H31FO6434.51 Gerald Hsu ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Miconazole Related Revision MICONAZOLE PF 41(5) Pg. ONLINE Compound C RS Clydewyn Anthony

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 Revision MYRISTIC ACID PF 42(5) Pg. ONLINE RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Palmitic Acid RS Galina Holloway

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 Revision NAPROXEN PF 42(4) Pg. ONLINE Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen 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 Revision NAPROXEN ORAL SUSPENSION PF 42(4) Pg. ONLINE RS Sujatha Ramakrishna

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 Revision NAPROXEN DELAYED-RELEASE TABLETS PF 42(4) Pg. ONLINE Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen 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 Revision NAPROXEN SODIUM PF 42(4) Pg. ONLINE <11>/USP Naproxen Related Compound L RS Richard Nguyen

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 New NEBIVOLOL TABLETS PF 41(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Hydrochloride RS Sujatha Ramakrishna

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 New NEBIVOLOL HYDROCHLORIDE PF 41(5) Pg. ONLINE Related Compound E RS Sujatha Ramakrishna

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 Revision NICOTINE TRANSDERMAL SYSTEM PF 42(2) Pg. ONLINE Related Compound E RS Ravi Ravichandran

IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Revision NORETHINDRONE TABLETS PF 42(1) Pg. ONLINE Standards <11>/USP Norethindrone Related Compound B RS Ren-Hwa Yeh 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 Revision NORETHINDRONE ACETATE TABLETS PF 42(1) Pg. ONLINE Related Compound B RS Ren-Hwa Yeh

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 Revision OLANZAPINE AND FLUOXETINE CAPSULES PF 42(5) Pg. ONLINE Olanzapine RS Gerald Hsu Revision OXAPROZIN PF 42(4) Pg. ONLINE IMPURITIES/Organic Impurities Hillary Cai 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 Revision PALMITIC ACID PF 42(3) Pg. ONLINE Myristic Acid RS Galina Holloway

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 Revision PENTAZOCINE PF 42(5) Pg. ONLINE TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Labeling Hillary Cai

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 Revision PENTAZOCINE HYDROCHLORIDE PF 42(3) Pg. ONLINE <466>, IMPURITIES/Organic Impurities Hillary Cai

Chemical Info/Pyridinium, 2-[(hydroxyimino)methyl]-1-methyl-, chloride (E)-;, Chemical Info/(E)-2-Formyl-1-methylpyridinium chloride oxime, Chemical Info/Chemical Name 14018-50-9 Unspecified isomerChemical Info/CAS, IDENTIFICATION/Infrared Absorption <197M>, ASSAY/Procedure, IMPURITIES/Organic Revision PRALIDOXIME CHLORIDE PF 42(6) Pg. ONLINE Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Elena Gonikberg

IDENTIFICATION/Infrared Absorption <197M>, ASSAY/Procedure, IMPURITIES/Organic Revision PRALIDOXIME CHLORIDE FOR INJECTION PF 42(6) Pg. ONLINE Impurities, SPECIFIC TESTS/Completeness of Solution <641> Elena Gonikberg

Title, Chemical Info/Chemical Structure, Chemical Info/C20H20FNO3S·HCl, Chemical Info/409.90, Chemical Info/Ethanone, 2-[2-(acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin- 5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)-, hydrochloride;, Chemical Info/5-[2- Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities 1, IMPURITIES/Organic Impurities 2, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prasugrel New PRASUGREL HYDROCHLORIDE PF 43(1) Pg. ONLINE Hydrochloride RS Donald Min IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision PREDNISONE PF 42(2) Pg. ONLINE Standards <11>/USP Cortisone RS Ren-Hwa Yeh

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Promethazine Revision PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES PF 42(2) Pg. ONLINE Related Compound B RS Ren-Hwa Yeh

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 New RALTEGRAVIR TABLETS PF 42(5) Pg. ONLINE Compound E RS Shankari Shivaprasad

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 New RALTEGRAVIR CHEWABLE TABLETS PF 42(5) Pg. ONLINE Compound E RS Shankari Shivaprasad

IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, Revision RESERPINE PF 42(6) Pg. ONLINE IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Revision RESERPINE TABLETS PF 42(6) Pg. ONLINE Impurities, SPECIFIC TESTS/Other Alkaloids Donald Min

Title, Chemical Info/Chemical Structure, Chemical Info/C17H26N2O, Chemical Info/274.40, Chemical Info/(S)-(-)-1-Propylpiperidine-2-carboxylic acid (2,6- dimethylphenyl)-amide;, Chemical Info/(S)-(-)-1-Propyl-2′,6′- pipecoloxylidide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ropivacaine Related Compound A, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Color, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference New ROPIVACAINE PF 43(1) Pg. ONLINE Standards <11>/USP Ropivacaine Related Compound B RS Ren-Hwa Yeh 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 Revision SALICYLIC ACID TOPICAL FOAM PF 41(2) Pg. ONLINE Related Compound B RS Sujatha Ramakrishna

DEFINITION/Introduction, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Revision SCOPOLAMINE HYDROBROMIDE PF 42(3) Pg. ONLINE Reference Standards <11>/USP Norscopolamine RS Feiwen Mao 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 New SODIUM LAUROYL SARCOSINATE PF 42(2) Pg. ONLINE Standards <11>/USP Sodium Myristoyl Sarcosinate RS Hong Wang IDENTIFICATION/A., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/USP Reference Revision SODIUM FLUORIDE ORAL SOLUTION PF 43(1) Pg. ONLINE Standards <11>/USP Sodium Chloride RS Michael Chang

IDENTIFICATION/A., IDENTIFICATION/B. Identification Tests-General <191>, Phosphate, ASSAY/Procedure 1, ASSAY/2, SPECIFIC TESTS/Other Requirements, SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION PF 43(1) Pg. ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Revision ONLINE Standards <11>/USP Sodium Chloride RS Michael Chang

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 Revision SPIRONOLACTONE PF 42(1) Pg. ONLINE Related Compound I RS Donald Min

DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Revision TELMISARTAN PF 43(1) Pg. ONLINE Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min

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 Revision TESTOSTERONE PF 41(4) Pg. ONLINE Reference Standards <11>/USP Testosterone Related Compound I RS Ren-Hwa Yeh 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 New TESTOSTERONE TOPICAL GEL PF 41(6) Pg. ONLINE Related Compound C RS Ren-Hwa Yeh

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 New TRANEXAMIC ACID INJECTION PF 42(1) Pg. ONLINE Tranexamic Acid Related Compound C RS Sujatha Ramakrishna IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE Revision TRANYLCYPROMINE TABLETS PF 42(4) Pg. ONLINE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Sridevi Ramachandran IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Revision TRETINOIN CREAM PF 41(4) Pg. ONLINE Standards <11>/USP Isotretinoin RS Feiwen Mao IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Revision TRETINOIN GEL PF 42(1) Pg. ONLINE Standards <11>/USP Isotretinoin RS Feiwen Mao

Chemical Info/Chemical Name 6-Phenylpteridine-2,4,7-triamine, IDENTIFICATION/Infrared Absorption <197M>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of 2,4,6-Triamino-5-nitrosopyrimidine, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamterene Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamterene Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamterene Revision TRIAMTERENE PF 42(6) Pg. ONLINE Related Compound C RS Donald Min

DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms Revision TRIHEXYPHENIDYL HYDROCHLORIDE ORAL SOLUTION PF 42(5) Pg. ONLINE <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Sridevi Ramachandran

IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tropicamide Related Compound A RS N-(Pyridin-4- ylmethyl)ethanamine.C8H12N2 136.19, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Tropicamide Related Compound B RS N-Ethyl-2-phenyl-N- (pyridin-4-ylmethyl)acrylamide.C17H18N2O 266.34, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tropicamide Related Compound C RS 3-Hydroxy-2- phenylpropionic acid.C9H10O3 166.17, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tropicamide Related Compound D RS 2-Phenylacetic Revision TROPICAMIDE OPHTHALMIC SOLUTION PF 42(6) Pg. ONLINE acid.C8H8O2 136.15 Ramanujam Prasad New UNDECANOIC ACID PF 42(4) Pg. ONLINE Undecanoic Acid Hong Wang 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 Revision WHITE WAX PF 42(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Hong Wang

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 Revision YELLOW WAX PF 42(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Hong Wang

ASSAY/Procedure, IMPURITIES/Limit of Triphenylmethanol and Other Impurities, IMPURITIES/Limit of Zidovudine Related Compounds B and C, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Triphenylmethanol, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triphenylmethanol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Zidovudine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Zidovudine Revision ZIDOVUDINE PF 43(1) Pg. ONLINE Related Compound C RS Thymine.C5H6N2O2126.12 Shankari Shivaprasad

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Zidovudine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision ZIDOVUDINE ORAL SOLUTION PF 43(1) Pg. ONLINE Zidovudine Related Compound C RS Shankari Shivaprasad

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 New ZINC SULFATE COMPOUNDED INJECTION PF 41(2) Pg. ONLINE Reference Standards <11>/USP Zinc Sulfate RS Jeanne Sun

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 Revision ZIPRASIDONE HYDROCHLORIDE PF 42(1) Pg. ONLINE Reference Standards <11>/USP Ziprasidone Related Compound F RS Sridevi Ramachandran