Compendial Deferrals for USP41-NF36 1S

Category Monograph Title Monograph Section Scientific Liaison

Revision USP AND NF EXCIPIENTS, LISTED BY CATEGORY PF 42(2) Pg. ONLINE{Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent} Hong Wang

Revision<5> INHALATION AND NASAL DRUG PRODUCTS GENERAL INFORMATION AND PRODUCT QUALITY TESTS PF 43(1) Pg. ONLINE

Introduction, 1. INTRODUCTION, 2. GENERAL QUALITY TESTS FOR INHALATION DRUG PRODUCTS, 3. GENERAL QUALITY TESTS FOR NASAL DRUG PRODUCTS, 4. DESCRIPTION OF PRODUCT QUALITY TESTS Kahkashan Zaidi

New DESCRIPTION AND SOLUBILITY PF 43(1) Pg. ONLINE

Bendamustine Hydrochloride, Ropivacaine, Bortezomib, Sodium Lauroyl Sarcosinate, Epinastine Hydrochloride, Imipramine Hydrochloride, Carglumic Acid, Iloperidone, Benzphetamine Hydrochloride, Deferasirox, Eletriptan Hydrobromide, Milnacipran Hydrochloride, Nebivolol Hydrochloride Feiwen Mao

New <64> PROBIOTIC TESTS - GENERAL PF 43(2) Pg. ONLINE

Title, INTRODUCTION/Introduction, PROCEDURE/Identification, PROCEDURE/Enumeration, PERFORMANCE TESTS/, CONTAMINANTS/Introduction, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Storage, ADDITIONAL REQUIREMENTS/Labeling, ??UNKNOWN??/Introduction Seong Jae Yoo

New <381> ELASTOMERIC CLOSURES FOR INJECTIONS PF 43(3) Pg. ONLINE

Title, Introduction, INTRODUCTION, CHARACTERISTICS, IDENTIFICATION, TEST PROCEDURES, BIOLOGICAL TESTS, PHYSICOCHEMICAL TESTS, FUNCTIONALITY TESTS, 1. INTRODUCTION, 2. SCOPE, 3. SPECIFICATIONS, 4. TEST METHODS Desmond Hunt

New<382> ELASTOMERIC CLOSURE FUNCTIONALITY IN INJECTABLE PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS PF 43(3) Pg. ONLINE

Title, 1. INTRODUCTION, 2. SCOPE, 3. GENERAL TEST REQUIREMENTS, 4. PACKAGE INTEGRITY, 5. NEEDLE AND SPIKE ACCESS FUNCTIONALITY TESTS, 6. PLUNGER FUNCTIONALITY TESTS, 7. TIP CAP AND NEEDLE SHIELD FUNCTIONALITY TESTS Desmond Hunt

Revision <467> RESIDUAL SOLVENTS PF 43(2) Pg. ONLINE

Introduction, 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, 1. INTRODUCTION, 2. CLASSIFICATION OF RESIDUAL SOLVENTS BY RISK ASSESSMENT, 3. CONTROL STRATEGY, 4. LIMITS OF RESIDUAL SOLVENTS, 5. OPTIONS FOR DESCRIBING LIMITS OF CLASS 2 AND CLASS 3 RESIDUAL SOLVENTS, 6. REPORTING LEVELS OF RESIDUAL SOLVENTS, 7. IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS, 8. ANALYTICAL PROCEDURES FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS, 9. ANALYTICAL PROCEDURES FOR CLASS 3 RESIDUAL SOLVENTS, APPENDICES, 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 Edmond Biba

New <509> RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE

Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Elena Curti

Revision<601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND POWDERS--PERFORMANCE QUALITY TESTS PF 42(6) Pg. ONLINE

TABLE OF CONTENTS, INTRODUCTION, A. DELIVERED-DOSE UNIFORMITYDELIVERED CONTENT UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS AND SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION-INHALATION AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi

Revision <660> CONTAINERS -- GLASS PF 43(3) Pg. ONLINE Title, Introduction, SCOPE, DESCRIPTION, SPECIFIC TESTS Desmond Hunt

New<665> POLYMERIC COMPONENTS AND SYSTEMS USED IN THE MANUFACTURING OF PHARMACEUTICAL AND BIOPHARMACEUTICAL DRUG PRODUCTS PF 43(3) Pg. ONLINE

Title, Introduction, 1. INTRODUCTION, 2. SCOPE, 3. ASSESSMENT PROCESS, 4. POLYMERIC MATERIALS OF CONSTRUCTION, 5. POLYMERIC COMPONENTS AND SYSTEMS Desmond Hunt

New <856> NEAR-INFRARED SPECTROSCOPY PF 42(2) Pg. ONLINE

2. QUALIFICATION OF NIR SPECTROMETERS, 3. PROCEDURE, 4. VALIDATION AND VERIFICATION, 1. INTRODUCTION, 2. QUALIFICATION OF NIR SPECTROMETERS, USP REFERENCE STANDARDS <11> Kahkashan Zaidi

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

New<915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY PENETROMETRY PF 43(2) Pg. ONLINE Title, INTRODUCTION, PROCEDURE, GLOSSARY Antonio Hernandez-Cardoso

Revision<1090> ASSESSMENT OF DRUG PRODUCT PERFORMANCE--BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION PF 42(4) Pg. ONLINE

Title, BACKGROUND, BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION, BIOEQUIVALENCE, DISSOLUTION AND IN VITRO PRODUCT PERFORMANCE, BIOWAIVER, APPENDIX William Brown

Revision <1119> NEAR-INFRARED SPECTROSCOPY PF 41(1) Pg. ONLINE

INTRODUCTION, INSTRUMENTATION, METHOD VALIDATION, GLOSSARY, *No Head*, 1. THEORY, 2. TRANSMISSION, REFLECTION, AND TRANSFLECTION MODES, 3. FACTORS THAT AFFECT NIR SPECTRA, 4. PRETREATMENT OF NIR SPECTRAL DATA, 5. INSTRUMENTATION, 6. APPLICATIONS, 7. PROCEDURE VALIDATION, 8. APPENDIX: GLOSSARY Kahkashan Zaidi

New<1168> COMPOUNDING FOR PHASE I INVESTIGATIONAL STUDIES PF 43(3) Pg. ONLINE

Title, Introduction, 1. INTRODUCTION, 2. PERSONNEL TRAINING, 3. BUILDINGS AND FACILITIES, 4. EQUIPMENT AND COMPONENTS, 5. STANDARD OPERATING PROCEDURES, 6. PREPARATION ACTIVITIES, 7. RELEASE OF INVESTIGATIONAL AGENT/PREPARATION, 8. LABELING, 9. ESTABLISHING BEYOND-USE DATES, 10. QUALITY ASSURANCE AND QUALITY CONTROL, 11. STORAGE, HANDLING, PACKAGING, AND TRANSPORT, 12. DOCUMENTATION, APPENDIX Jeanne Sun

New <1236> SOLUBILITY MEASUREMENTS PF 43(2) Pg. ONLINETitle, INTRODUCTION, BACKGROUND, EXPERIMENTAL METHODS, SOLUBILITY MEASUREMENTS IN BIO-RELEVANT MEDIA, GLOSSARY, REFERENCES Antonio Hernandez-Cardoso

New<1381> ELASTOMERIC EVALUATION OF ELASTOMERIC COMPONENTS USED IN PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS PF 43(3) Pg. ONLINE

Title, Introduction, 1. INTRODUCTION, 2. SCOPE, 3. DESCRIPTION OF ELASTOMERIC COMPONENTS IN PACKAGING SYSTEMS, 4. ELASTOMERIC COMPONENTS-MATERIALS OF CONSTRUCTION, 5. ELASTOMERIC COMPONENTS-MANUFACTURING TECHNOLOGY AND STERILIZATION PROCEDURES, 6. TEST PROCEDURES Desmond Hunt

New<1382> ASSESSMENT OF ELASTOMERIC CLOSURE FUNCTIONALITY IN INJECTABLE PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS PF 43(3) Pg. ONLINE

Title, 1. INTRODUCTION, 2. EARLY PACKAGE DEVELOPMENT: CLOSURE FUNCTIONALITY ASSESSMENT, 3. ASSESSMENT OF THE FITNESS OF FUNCTIONALITY TEST FOR ITS INTENDED USE, 4. CONCLUSION Desmond Hunt

New<1467> RESIDUAL SOLVENTS- VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES PF 43(2) Pg. ONLINE

Title, Introduction, VERIFICATION OF COMPENDIAL PROCEDURES, VALIDATION OF ALTERNATIVE PROCEDURES Edmond Biba

Revision<1660> EVALUATION OF THE INNER SURFACE DURABILITY OF GLASS CONTAINERS PF 43(3) Pg. ONLINE

Title, Introduction, PURPOSEINTRODUCTION, SCOPE, GLASS TYPES, FORMATION AND PROCESSINGOF MOLDED AND TUBULAR GLASS CONTAINERS, GLASS CONTAINER SOURCING, GLASS SURFACE CHEMISTRY, FACTORS THAT INFLUENCE INNER SURFACE DURABILITY, EVALUATION OF THE INNER SURFACE DURABILITY, CONCLUSIONSSUMMARY Desmond Hunt

New<1665> PLASTIC COMPONENTS AND SYSTEMS USED TO MANUFACTURE PHARMACEUTICAL DRUG PRODUCTS PF 43(3) Pg. ONLINE

Title, 1. INTRODUCTION, 2. SCOPE, 3. GENERAL PRINCIPLES, 4. CHARACTERIZATION PROCESS, 5. SAFETY QUALIFICATION, GLOSSARY Desmond Hunt

Revision <1858> RAMAN SPECTROSCOPY - THEORY AND PRACTICE PF 40(6) Pg. ONLINE

Title, INTRODUCTION, QUALITATIVE AND QUANTITATIVE RAMAN MEASUREMENTS, FACTORS AFFECTING QUANTIFICATION, APPARATUS, QUALIFICATION AND VERIFICATION OF RAMAN SPECTROMETERS, METHOD VALIDATION, DEFINITION OF TERMS AND SYMBOLS, THEORY, SAMPLING FACTORS, SPECIALIZED TECHNIQUES, CALIBRATION, FACTORS THAT AFFECT MEASUREMENT PERFORMANCE, PROCEDURE VALIDATION Kahkashan Zaidi

New <1912> MEASUREMENT OF HARDNESS OF SEMISOLIDS PF 43(2) Pg. ONLINE Title, BACKGROUND, EXPERIMENTAL METHODS, GLOSSARY, REFERENCES Antonio Hernandez-Cardoso

New ACAMPROSATE DELAYED-RELEASE TABLETS PF 41(6) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Limit of Acamprosate Related Compound A, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acamprosate Calcium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acamprosate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acamprosate Related Compound B RS Heather Joyce

Revision ACETAMINOPHEN TABLETS PF 42(3) Pg. ONLINEIDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure Clydewyn Anthony

New

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE ORAL SUSPENSION PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Deliverable Volume <698>, IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetaminophen RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Aminophenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorpheniramine Maleate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Hydrochloride RS Clydewyn Anthony

NewACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetaminophen RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Aminophenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dextromethorphan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guaifenesin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound F RS Clydewyn Anthony

NewACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetaminophen RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guaifenesin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound F RS Clydewyn Anthony

Revision ACETAZOLAMIDE TABLETS PF 42(6) Pg. ONLINE

ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetazolamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetazolamide Related Compound E RS Ramanujam Prasad

Revision ALBUMIN HUMAN PF 41(6) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Immunodiffusion, IDENTIFICATION/B. Protein Composition by Zone Electrophoresis, ASSAY/Procedure, OTHER COMPONENTS/Content of Sodium Caprylate, OTHER COMPONENTS/Content of N-Acetyl-dl-tryptophan, IMPURITIES/Prekallikrein Activator <165>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Biological Reactivity tests <88>, In Vivo, Safety Tests-Biologicals, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Molecular Weight Distribution, SPECIFIC TESTS/Heat Stability, SPECIFIC TESTS/Content of Sodium, SPECIFIC TESTS/Limit of Potassium, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Kevin Carrick

Revision ALBUTEROL TABLETS PF 41(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B. Identification Tests-General, Sulfate <191>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levalbuterol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levalbuterol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levalbuterol Related Compound E RS Mary Koleck

Revision ALCLOMETASONE DIPROPIONATE CREAM PF 43(1) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate RS Mary Koleck

Revision ALCLOMETASONE DIPROPIONATE OINTMENT PF 43(1) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate RS Mary Koleck

New ALOSETRON HYDROCHLORIDE PF 43(2) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C17H18N4O·HCl, Chemical Info/330.82, Chemical Info/1H-Pyrido[4,3-b]indol-1-one, 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-, hydrochloride;, Chemical Info/2,3,4,5-Tetrahydro-5-methyl-2-[(5-methylimidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one 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, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Related Compound A RS Andrea Carney

New ALOSETRON TABLETS PF 43(2) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Related Compound A RS Andrea Carney

Revision ALPRAZOLAM TABLETS PF 41(6) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alprazolam Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlordiazepoxide Related Compound A RS Heather Joyce

Revision AMINOBENZOIC ACID GEL PF 43(2) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/A., ASSAY/Procedure Sujatha Ramakrishna

Revision AMITRIPTYLINE HYDROCHLORIDE TABLETS PF 43(3) Pg. ONLINE

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

Revision AMOXICILLIN FOR ORAL SUSPENSION PF 42(6) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound H RS Ramanujam Prasad

New ANNATTO SEED TOCOTRIENOLS EXTRACT PF 42(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Procedure, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Water Determination <921>, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Annatto Seed Tocotrienols Extract RS Huy Dinh

Revision ASPIRIN PF 41(6) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197K> or <197A>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Substances Insoluble in Sodium Carbonate TS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid RS Clydewyn Anthony

Revision ATROPINE PF 43(1) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Foreign Alkaloids and Other Impurities, IMPURITIES/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Atropine RS Heather Joyce

Revision AZATHIOPRINE TABLETS PF 43(3) Pg. ONLINE

IDENTIFICATION/Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azathioprine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mercaptopurine RS Feiwen Mao

New AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Osmolality and Osmolarity <785>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azelastine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azelastine Related Compound F RS Mary Koleck

Revision AZITHROMYCIN PF 43(3) Pg. ONLINE

IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/, Procedure 2, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP N-Demethylazithromycin RS (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-&alpha;-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-methylamino-&beta;-d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. C37H70N2O12 734.96 Praveen Pabba

New BACILLUS COAGULANS PF 43(1) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/Nucleic Acid-Based Identification, ASSAY/Enumeration, SPECIFIC TESTS/Loss on Drying <731>, CONTAMINANTS/Yeasts, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Escherichia coli and Test for Absence of Salmonella Species, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Seong Jae Yoo

New BACILLUS COAGULANS CAPSULES PF 43(1) Pg. ONLINE

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

New BENDAMUSTINE HYDROCHLORIDE PF 43(1) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C16H21Cl2N3O2·HCl, Chemical Info/394.72, Chemical Info/1H-Benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, monohydrochloride;, Chemical Info/4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazole-2-yl}butanoic acid monohydrochloride, Chemical Info/CAS, Chemical Info/Bendamustine (free base), Chemical Info/C16H21Cl2N3O2, Chemical Info/358.26, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound I RS Feiwen Mao

New BENDAMUSTINE HYDROCHLORIDE FOR INJECTION PF 43(1) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, PERFORMANCE TESTS/ Uniformity of Dosage Units <905>, Weight Variation, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/ Sterility Tests <71>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling <7>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bendamustine Related Compound I RS Feiwen Mao

New BENZPHETAMINE HYDROCHLORIDE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C17H21N·HCl, Chemical Info/275.82, Chemical Info/(+)-N-Benzyl-N,&alpha;-dimethylphenethylamine hydrochloride;, Chemical Info/(S)-N-Benzyl-N-methyl-1-phenylpropan-2-amine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Benzyl Chloride, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzphetamine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzphetamine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzphetamine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzphetamine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzyl Chloride RS Wei Yang

New BENZPHETAMINE HYDROCHLORIDE TABLETS PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzphetamine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzphetamine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methamphetamine Hydrochloride RS Wei Yang

Revision BETAMETHASONE PF 43(2) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clobetasol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone RS Mary Koleck

Revision BETAMETHASONE ACETATE PF 42(5) Pg. ONLINE

IDENTIFICATION/Infrared Absorption <197M>, IDENTIFICATION/Thin-Layer Chromatographic Identification Test <201>, ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Acetate Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Acetate Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS Mary Koleck

Revision BETAMETHASONE DIPROPIONATE CREAM PF 42(6) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound C RS Mary Koleck

Revision BETAMETHASONE DIPROPIONATE LOTION PF 42(6) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound C RS Mary Koleck

New BORTEZOMIB PF 42(6) Pg. ONLINE

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

New BORTEZOMIB FOR INJECTION PF 42(6) Pg. ONLINE

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

New BUDESONIDE DELAYED-RELEASE CAPSULES PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound L RS Mary Koleck

New CALCIUM ACETATE CAPSULES PF 43(2) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Identification Tests-General <191>, Acetate, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Calcium Acetate RS Michael Chang

RevisionCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS PF 43(2) Pg. ONLINE

PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Candesartan Cilexetil Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Candesartan Cilexetil Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Candesartan Cilexetil Related Compound F RS Sujatha Ramakrishna

Revision CARBINOXAMINE MALEATE TABLETS PF 42(2) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound B RS Mary Koleck

New CARGLUMIC ACID PF 41(6) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C6H10N2O5, Chemical Info/190.15, Chemical Info/l-Glutamic acid, N-(aminocarbonyl)-;, Chemical Info/N-Carbamoyl-l-glutamic acid, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of d-Carglumic acid, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Optical Rotation <781>, Procedures, Specific Rotation, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carglumic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP d-Carglumic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carglumic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carglumic Acid Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carglumic Acid Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Glutamic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyroglutamic Acid RS Sujatha Ramakrishna

New CAROTENES PF 43(2) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., COMPOSITION/Content of Total Carotenes, COMPOSITION/Content of Alpha and Beta Carotene, SPECIFIC TESTS/Limit of Gamma Carotene and Lycopene, SPECIFIC TESTS/Microbial Enumeration Tests <2021>, SPECIFIC TESTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species, Test for Absence of Escherichia coli, and Test for Absence of Staphylococcus aureus, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, 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 Carotenes RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Beta Carotene RS Huy Dinh

Revision CASTOR OIL PF 41(5) Pg. ONLINE

Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Identity by Fatty Acid Composition, IDENTIFICATION/B. Distinction from Most Other Fixed Oils, ASSAY/Triglyceride Composition, SPECIFIC TESTS/Distinction from Most Other Fixed Oils, SPECIFIC TESTS/Fats and Fixed Oils <401>, Free Fatty Acids, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Hydroxyl Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Fats and Fixed Oils, Iodine Value <401>, SPECIFIC TESTS/Fats and Fixed Oils <401>, Unsaponifiable Matter, SPECIFIC TESTS/Water Determination <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/Other Requirements, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang

New CELECOXIB CAPSULES PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound C RS Wei Yang

New CHELATING ION EXCHANGE RESIN PF 41(3) Pg. ONLINE Chelating Ion-Exchange Resin Trish LiNew CHLOROMETHYLNITROIMIDAZOLE PF 43(3) Pg. ONLINE Chloromethylnitroimidazole Sridevi Ramachandran

New CHOLINE FENOFIBRATE PF 42(6) Pg. ONLINE

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

New CITICOLINE SODIUM PF 42(6) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C14H25N4NaO11P2, Chemical Info/510.31, Chemical Info/Cytidine 5\'-(trihydrogen diphosphate), P\'-[2-(trimethylammonio)ethyl] ester, inner salt, monosodium salt;, Chemical Info/CDP-choline (sodium), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Chloride and Sulfate <221>, Chloride, IMPURITIES/Related Compounds, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Citicoline Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 5&prime;-Cytidylic Acid RS Huy Dinh

Revision CLOMIPRAMINE HYDROCHLORIDE PF 42(3) Pg. ONLINE

IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Heavy Metals, Method II <231>, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound F RS Heather Joyce

Revision CLOMIPRAMINE HYDROCHLORIDE CAPSULES PF 42(3) Pg. ONLINE

IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clomipramine Related Compound C RS Heather Joyce

Revision CORTISONE ACETATE PF 43(2) Pg. ONLINE

IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydrocortisone Acetate RS Mary Koleck

Revision CORTISONE ACETATE TABLETS PF 43(2) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydrocortisone Acetate RS Mary Koleck

Revision CYCLOPHOSPHAMIDE FOR INJECTION PF 43(1) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities: Procedure for the Sterile Powder Formulation, IMPURITIES/Organic Impurities: Procedure for the Lyophilized Formulation, IMPURITIES/Limit of Cyclophosphamide Related Compound C: Procedure for the Lyophilized Formulation, SPECIFIC TESTS/Limit of Chloride for the Lyophilized Formulation, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound D RS Feiwen Mao

Revision CYCLOSPORINE PF 43(1) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Slavica Shane

Revision CYCLOSPORINE CAPSULES PF 43(1) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure for Where Capsules Contain Liquid, ASSAY/Procedure for Where Capsules Contain Powder, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclosporine Resolution Mixture RS Slavica Shane

Revision CYCLOSPORINE INJECTION PF 43(1) Pg. ONLINE

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

Revision CYCLOSPORINE ORAL SOLUTION PF 43(1) Pg. ONLINE

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

Revision CYPROHEPTADINE HYDROCHLORIDE TABLETS PF 43(1) Pg. ONLINE IMPURITIES/Organic Impurities Mary Koleck

New DEFERASIROX PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C21H15N3O4, Chemical Info/373.36, Chemical Info/Benzoic acid, 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-;, Chemical Info/4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Deferasirox RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Deferasirox System Suitability Mixture RS Andrea Carney

Revision DESOXIMETASONE PF 42(1) Pg. ONLINEIDENTIFICATION/B. Thin-Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure Mary Koleck

Revision DEXAMETHASONE PF 42(4) Pg. ONLINE

IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desoximetasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS Mary Koleck

Revision DEXAMETHASONE OPHTHALMIC SUSPENSION PF 43(3) Pg. ONLINE

IDENTIFICATION/Thin-Layer Chromatography, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS Mary Koleck

Revision DEXAMETHASONE SODIUM PHOSPHATE INJECTION PF 43(3) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Sodium Phosphate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Mary Koleck

Revision DEXTROSE EXCIPIENT PF 42(6) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Related Substances, SPECIFIC TESTS/Optical Rotation <781S>, Specific Rotation, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Galina Holloway

Revision DIHYDROCODEINE BITARTRATE PF 43(3) Pg. ONLINE

Chemical Info/4,5&alpha;-Epoxy-3-methoxy-17-methylmorphinan-6&alpha;-ol (+)-tartrate (salt)5965-13-9, Chemical Info/Chemical Name Dihydrocodeine (free base)C18H23NO3301.39 125-28-0 Chemical Info/CAS, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Ammonium Salts, SPECIFIC TESTS/Melting Range or Temperature <741>, Class I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Codeine Sulfate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Morphine Sulfate RS Wei Yang

New 7,8-DIHYDROFOLIC ACID PF 42(5) Pg. ONLINE 7,8-Dihydrofolic Acid K. Seela

Revision DIPYRIDAMOLE TABLETS PF 41(3) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dipyridamole Related Compound F RS Sujatha Ramakrishna

Revision DOXYLAMINE SUCCINATE PF 42(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/B. Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Volatile Related Compounds, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class I <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound C RS Richard Nguyen

Revision DOXYLAMINE SUCCINATE TABLETS PF 42(3) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbinoxamine Related Compound C RS Richard Nguyen

New ELETRIPTAN HYDROBROMIDE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C22H26N2O2S·HBr, Chemical Info/463.43, Chemical Info/C22H26N2O2S·HBr·H2O, Chemical Info/481.45, Chemical Info/(R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide;, Chemical Info/3-{[(R)-1-Methyl-2-pyrrolidinyl]methyl}-5-[2-(phenylsulfonyl)ethyl]indole, monohydrobromide, Chemical Info/CAS, Chemical Info/Monohydrate, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Bromide, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Eletriptan S-Enantiomer, IMPURITIES/Limit of Isopropyl p-Toluenesulfonate (if present), IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, SPECIFIC TESTS/Water Determination <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Eletriptan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Eletriptan Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Eletriptan S-Enantiomer RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isopropyl p-Toluenesulfonate RS Heather Joyce

New EPINASTINE HYDROCHLORIDE PF 43(2) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C16H15N3·HCl, Chemical Info/285.78, Chemical Info/1H-Dibenzo[c,f]imidazo[1,5-a]azepin-3-amine, 9,13b-dihydro-, hydrochloride;, Chemical Info/3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine 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, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinastine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinastine Related Compound A RS Gerald Hsu

Revision EPINEPHRINE PF 42(6) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Adrenalone, IMPURITIES/Limit of Norepinephrine, IMPURITIES/Enantiomeric Purity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Adrenalone Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norepinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Racepinephrine Hydrochloride RS Sujatha Ramakrishna

Revision EPINEPHRINE INJECTION PF 43(3) Pg. ONLINE

IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Enantiomeric Purity, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Racepinephrine Hydrochloride RS Gerald Hsu

New EPTACOG ALFA ACTIVATED PF 41(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C1982H3054N560O618S28, Chemical Info/INS: (The chemical formula includes the &gamma;-carboxylations and modification of D (Asp) in position 63, and does not include the glycosylations.), Chemical Info/&ape;50,000 (The molecular weight includes the glycosylation.), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Peptide Mapping, ASSAY/Concentration of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Gla-Domainless Eptacog Alfa (&gamma;-Carboxylation), IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, IMPURITIES/Non-Activated Factor VII (Single Chain), SPECIFIC TESTS/Glycan Analysis, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa for Bioassay RS Kevin Carrick

New EPTACOG ALFA ACTIVATED FOR INJECTION PF 41(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Content of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, SPECIFIC TESTS/Water Determination <921>, Method 1c, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, Test for Sterility of the Product to Be Examined, Membrane Filtration, SPECIFIC TESTS/Constituted Solution, ADDITIONAL REQUIREMENTS/Packaging and Storage Requirements <659>, Injection Packaging, Sterile solids packaging, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa for Bioassay RS Kevin Carrick

Omission ERGOTAMINE TARTRATE INHALATION AEROSOL PF 43(2) Pg. ONLINE Entire document Ravi Ravichandran

Revision ESTRIOL PF 43(3) Pg. ONLINE

IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Completeness of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Estradiol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Estriol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Estrone RS Gerald Hsu

New ESTRIOL COMPOUNDED VAGINAL CREAM PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Estriol RS Jeanne Sun

Omission ETHOTOIN PF 43(3) Pg. ONLINE Entire document Heather JoyceOmission ETHOTOIN TABLETS PF 43(3) Pg. ONLINE Entire document Heather Joyce

New EUROPEAN ELDER BERRY DRY EXTRACT PF 43(2) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Anthocyanosides and Cyanidin, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species, and Test for Absence of Escherichia coli, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyanidin-3-O-Glucoside Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyanidin Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP European Elder Berry Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rutin RS Cuiying Ma

New EVEROLIMUS PF 42(6) Pg. ONLINE

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

New FENOFIBRIC ACID DELAYED-RELEASE CAPSULES PF 42(6) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fenofibric Acid RS Sujatha Ramakrishna

Revision FLECAINIDE ACETATE PF 42(2) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> <197>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Clarity of Solution Sujatha Ramakrishna

Revision FLECAINIDE ACETATE TABLETS PF 42(2) Pg. ONLINE

IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Sujatha Ramakrishna

Revision FLUDROCORTISONE ACETATE TABLETS PF 43(1) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone RS Gerald Hsu

Revision FLUDEOXYGLUCOSE F 18 INJECTION PF 43(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Radionuclidic Identity, IDENTIFICATION/B. Radiochemical Identity, ASSAY/Procedure, ASSAY/Radioactive Concentration (Strength), PURITY/Radionuclidic Purity, PURITY/Radiochemical Purity, IMPURITIES/Organic Impurities, IMPURITIES/Radionuclidic Impurities, IMPURITIES/Radiochemical Impurities, IMPURITIES/Limit of Aminopolyether, IMPURITIES/Limit of Fludeoxyglucose Related Compound A, IMPURITIES/Limit of 2-Chloro-2-Deoxy-D-Glucose, IMPURITIES/Limit of Fludeoxyglucose Related Compound B, IMPURITIES/Residual Solvents, IMPURITIES/Limit of Acetonitrile and Ethanol, SPECIFIC TESTS/Specific Activity, SPECIFIC TESTS/Appearance, SPECIFIC TESTS/ :<791>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol Determination-Alcohol RS Ravi Ravichandran

New FLUVASTATIN EXTENDED-RELEASE TABLETS PF 42(4) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluvastatin Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluvastatin for System Suitability RS Sujatha Ramakrishna

Revision FLUVOXAMINE MALEATE TABLETS PF 42(5) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Test 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Heather Joyce

Revision FONDAPARINUX SODIUM PF 42(5) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fondaparinux Sodium System Suitability Mixture B RS Kevin Carrick

Revision FONDAPARINUX SODIUM INJECTION PF 42(5) Pg. ONLINEIDENTIFICATION/B. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85> Kevin Carrick

Revision GENTAMICIN SULFATE PF 43(3) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., IMPURITIES/Organic Impurities, SPECIFIC TESTS/Content of Gentamicins Slavica Shane

Revision POWDERED DECAFFEINATED GREEN TEA EXTRACT PF 43(2) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/Thin-Layer Chromatographic Identification Test, IDENTIFICATION/Identification Test, COMPOSITION/Content of Polyphenols, SPECIFIC TESTS/Limit of Gallic Acid, SPECIFIC TESTS/Limit of Caffeine, ADDITIONAL REQUIREMENTS/Labeling Anton Bzhelyansky

New GUANIDINE HYDROCHLORIDE PF 42(4) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/CH5N3·HCl, Chemical Info/95.53, Chemical Info/Guanidine, hydrochloride (1:1);, Chemical Info/Guanidine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Chloride and Sulfate <221>, Sulfate, IMPURITIES/Limit of Nitrate, IMPURITIES/Limit of Cyanide, IMPURITIES/Residue on Ignition <281>, SPECIFIC TESTS/Acidity, SPECIFIC TESTS/Water-Insoluble Substances, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class 1, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guanidine Hydrochloride RS Galina Holloway

New ILOPERIDONE PF 42(1) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C24H27FN2O4, Chemical Info/426.48, Chemical Info/Ethanone, 1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]-;, Chemical Info/4&prime;-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3&prime;-methoxyacetophenone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chloropropyl Vanillin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iloperidone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iloperidone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Paliperidone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Vanillin RS Heather Joyce

Revision IMIPENEM PF 43(3) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Solvents, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Loss on Drying, SPECIFIC TESTS/Water Determination <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage Ramanujam Prasad

Revision ISOSORBIDE DINITRATE TABLETS PF 42(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, Performance Tests/Dissolution Sujatha Ramakrishna

New L115 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex CarboPac PA100) Trish LiNew L116 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex DNAPac PA100) Trish Li

New LACTULOSE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C12H22O11, Chemical Info/342.30, Chemical Info/d-Fructose, 4-O-&beta;-d-galactopyranosyl-;, Chemical Info/4-O-&beta;-d-Galactopyranosyl-d-fructofuranose, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epilactose RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lactose Monohydrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lactulose RS Andrea Carney

Revision LEUCOVORIN CALCIUM PF 42(5) Pg. ONLINE

IDENTIFICATION/Infrared Absorption<197K>, IDENTIFICATION/B. Identification Tests-General <191> , Calcium, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of 5-(&gamma;-Folinoyl)tetrahydrofolate, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Folic Acid RS Feiwen Mao

New LEUCOVORIN CALCIUM FOR INJECTION PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Folic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Leucovorin Calcium RS Feiwen Mao

Revision LIDOCAINE HYDROCHLORIDE PF 43(3) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption <197>, ASSAY/Procedure, IMPURITIES/Organic Impurities Richard Nguyen

Revision LIOTHYRONINE SODIUM PF 43(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C., IDENTIFICATION/D., ASSAY/Procedure, IMPURITIES/Chloride Content, SPECIFIC TESTS/Sodium Content, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levothyroxine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Liothyronine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Liothyronine Sodium RS Andrea Carney

Revision MAPROTILINE HYDROCHLORIDE PF 43(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Maprotiline Related Compound D RS Ren-Hwa Yeh

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

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 2,3-Dimethylaniline RS Hillary Cai

Revision MEGESTROL ACETATE PF 42(6) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate RSUSP Megestrol Acetate Related Compound C RS 6,13a&beta;-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 2&alpha;,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4398.54 ) Gerald Hsu

Revision MEGESTROL ACETATE TABLETS PF 42(6) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate RS USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene-17-yl acetate.(C24H32O4 384.51 )USP Megestrol Acetate Related Compound H RS 2&alpha;,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4 398.54 ) Gerald Hsu

Revision MESNA PF 43(1) Pg. ONLINE

IDENTIFICATION/B. Identification Tests-General, Sodium <191>, IDENTIFICATION/B., IDENTIFICATION/B, ASSAY/Procedure, IMPURITIES/Limit of Chloride, IMPURITIES/Limit of Sulfate, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying Hillary Cai

New MESNA INJECTION PF 43(1) Pg. ONLINE

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

New MESNA TABLETS PF 43(1) Pg. ONLINE

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

Revision METHOHEXITAL PF 42(5) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/<197S>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Gerald Hsu

Revision METHOHEXITAL SODIUM FOR INJECTION PF 42(5) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities Gerald Hsu

Revision METHOTREXATE PF 43(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1: Related Compounds, IMPURITIES/Organic Impurities, Procedure 2: Enantiomeric Purity, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methotrexate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methotrexate Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methotrexate Related Compound E RS Feiwen Mao

Revision METHYLPHENIDATE HYDROCHLORIDE PF 43(2) Pg. ONLINE IDENTIFICATION/C., IMPURITIES/Organic Impurities, Procedure 2 Mary Koleck

Revision METHYLPREDNISOLONE ACETATE PF 41(6) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS 9-Fluoro-11&beta;,17,21-trihydroxy-16&alpha;-methylpregna-1,4-diene-3,20-dione 21-acetate.C24H31FO6434.51 Gerald Hsu

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

New MILNACIPRAN HYDROCHLORIDE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C15H22N2O·HCl, Chemical Info/282.81, Chemical Info/Cyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-1-phenyl-, monohydrochloride, (1R,2S)-rel-;, Chemical Info/(1RS,2SR)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride;, Chemical Info/Z-2 Aminomethyl-1-phenyl-N,N-diethylcyclopropanecarboxamide hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Early Eluting Organic Impurities, IMPURITIES/Late Eluting Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound C RS (1RS,2SR)-2-[(1,3-Dioxoisoindolin-2-yl)methyl]-N,N-diethyl-1-phenylcyclopropane-1-carboxamide.C23H24N2O3376.46 Mary Koleck

New MILNACIPRAN HYDROCHLORIDE TABLETS PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound A RS (1RS,2SR)-2-(Aminomethyl)-1-phenylcyclopropane-1-carboxylic acid hydrochloride.C11H13NO2·HCl227.69, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milnacipran Related Compound B RS (1RS,5SR)-1-Phenyl-3-azabicyclo[3.1.0]hexan-2-one.C11H11NO173.21 Mary Koleck

Revision MYRISTIC ACID PF 42(5) Pg. ONLINE

IDENTIFICATION/B. Chromatographic Identity, ASSAY/Fats and Fixed Oils, Fatty Acid Composition <401>, ASSAY/Procedure, IMPURITIES/Limit of Lauric Acid and Palmitic Acid, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lauric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Palmitic Acid RS Galina Holloway

Revision NAPROXEN PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen

Revision NAPROXEN ORAL SUSPENSION PF 42(4) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Sujatha Ramakrishna

Revision NAPROXEN DELAYED-RELEASE TABLETS PF 42(4) Pg. ONLINE

IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Delayed-Release Dosage Forms, Method B Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen

Revision NAPROXEN SODIUM PF 42(4) Pg. ONLINE

IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen

Revision NARATRIPTAN TABLETS PF 43(2) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Gerald Hsu

New NEBIVOLOL TABLETS PF 41(5) Pg. ONLINE

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

New NEBIVOLOL HYDROCHLORIDE PF 41(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C22H25F2NO4·HCl, Chemical Info/441.90, Chemical Info/2H-1-Benzopyran-2-methanol, &alpha;,&alpha;&prime;-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro]-, hydrochloride, (&alpha;R,&alpha;&prime;R,2R,2&prime;S)-rel-;, Chemical Info/(1RS,1&prime;RS)-1,1&prime;-[(2RS,2&prime;SR)-Bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2&prime;-iminodiethanol hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Content of Nebivolol Related Compound C and Nebivolol Related Compound D, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound E RS Sujatha Ramakrishna

Revision NIFEDIPINE CAPSULES PF 43(2) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min

Revision AMMONIA N 13 INJECTION PF 43(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Radionuclidic Identity, IDENTIFICATION/B. Radiochemical Identity, ASSAY/Radioactive Concentration (Strength), PURITY/Radionuclidic Purity, PURITY/Radiochemical Purity, IMPURITIES/Radionuclidic Impurities, IMPURITIES/Radiochemical Impurities, IMPURITIES/Chemical Purity, IMPURITIES/Limit of Ethanol, SPECIFIC TESTS/ :<791>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Appearance, SPECIFIC TESTS/Specific Activity, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol Determination-Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Ravi Ravichandran

Revision NORETHINDRONE TABLETS PF 42(1) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone Related Compound B RS Ren-Hwa Yeh

Revision NORETHINDRONE ACETATE TABLETS PF 42(1) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone Related Compound B RS Ren-Hwa Yeh

Revision OLANZAPINE AND FLUOXETINE CAPSULES PF 42(5) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxetine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxetine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Olanzapine RS Gerald Hsu

Revision PALM OIL PF 43(2) Pg. ONLINE IDENTIFICATION/C. Identity by Triglyceride Profile Hong Wang

Revision PALMITIC ACID PF 42(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, IDENTIFICATION/B. Acid Value, ASSAY/Procedure, IMPURITIES/Limit of Stearic Acid, Myristic Acid, and Other Related Fatty Acids, SPECIFIC TESTS/Fats and Fixed Oils, Acid Value <401>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Myristic Acid RS Galina Holloway

Revision PAMABROM PF 43(2) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/8-Bromotheophylline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pamabrom Related Compound A RS Clydewyn Anthony

Revision PENTAZOCINE HYDROCHLORIDE PF 42(3) Pg. ONLINE

Chemical Info/Chemical Structure, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A., IDENTIFICATION/B. Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities Hillary Cai

Revision PHENTOLAMINE MESYLATE PF 43(3) Pg. ONLINE

IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phentolamine Amine Analog RS Donald Min

Revision PREDNISONE PF 42(2) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cortisone RS Ren-Hwa Yeh

Revision PRILOCAINE HYDROCHLORIDE INJECTION PF 43(2) Pg. ONLINE

IDENTIFICATION/A. Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prilocaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prilocaine Related Compound B RS Ren-Hwa Yeh

RevisionPROMETHAZINE AND PHENYLEPHRINE HYDROCHLORIDE ORAL SOLUTION PF 43(3) Pg. ONLINE

IDENTIFICATION/B., IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2 Sujatha Ramakrishna

Revision RESERPINE PF 42(6) Pg. ONLINEIDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min

Revision RESERPINE TABLETS PF 42(6) Pg. ONLINEIDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Other Alkaloids Donald Min

New ROPIVACAINE PF 43(1) Pg. ONLINE

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

Revision SALICYLIC ACID TOPICAL FOAM PF 41(2) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound B RS Sujatha Ramakrishna

Revision SALICYLIC ACID PLASTER PF 43(2) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound B RS Clydewyn Anthony

Revision SELENIUM SULFIDE TOPICAL SUSPENSION PF 43(3) Pg. ONLINEIDENTIFICATION/A., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang

New SODIUM LAUROYL SARCOSINATE PF 42(2) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/Glycine, N-methyl-N-(1-oxododecyl)-, sodium salt;, Chemical Info/Sodium N-dodecanoyl-N-methylglycinate;, Chemical Info/Sodium N-lauroyl-N-methylglycinate;, Chemical Info/Sodium [dodecanoyl(methyl)amino]acetate, Chemical Info/C15H28NNaO3, Chemical Info/293.38, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B. Chromatographic Identity, IDENTIFICATION/C. Presence of Sodium, ASSAY/Procedure, IMPURITIES/Limit of Sodium Decanoyl Sarcosinate and Sodium Myristoyl Sarcosinate, IMPURITIES/Limit of Sodium Sarcosinate, IMPURITIES/Limit of Sodium Laurate, IMPURITIES/Limit of Sodium Chloride, IMPURITIES/Limit of Sodium Sulfate, SPECIFIC TESTS/Acidity and Alkalinity, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lauric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Decanoyl Sarcosinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Lauroyl Sarcosinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Myristoyl Sarcosinate RS Hong Wang

Revision SODIUM THIOSULFATE INJECTION PF 43(2) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/Procedure, ASSAY/Procedure, IMPURITIES/Limit of Sulfate and Sulfite, IMPURITIES/Limit of Sulfide, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Sulfate Anhydrous RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Sulfide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Thiosulfate RS Donald Min

Revision SPIRONOLACTONE PF 42(1) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Epimer Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound I RS Donald Min

New TACROLIMUS OINTMENT PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Minimum Fill <755>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tacrolimus RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tacrolimus Related Compound A RS Praveen Pabba

Revision TERAZOSIN TABLETS PF 43(2) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Donald Min

Revision TESTOSTERONE PF 41(4) Pg. ONLINE

IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Exemestane Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound I RS Ren-Hwa Yeh

New TESTOSTERONE TOPICAL GEL PF 41(6) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Viscosity-Rotational Methods <912>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Related Compound C RS Ren-Hwa Yeh

Revision TESTOSTERONE ENANTHATE PF 43(3) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, IMPURITIES/Free Heptanoic Acid, IMPURITIES/Limit of Heptanoic Acid and Testosterone Enanthate Related Compound H, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Enanthic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound H RS Ren-Hwa Yeh

Revision TESTOSTERONE ENANTHATE INJECTION PF 43(3) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Heptanoic Acid, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Enanthic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Enanthate Related Compound G RS Ren-Hwa Yeh

Revision TETRACYCLINE HYDROCHLORIDE PF 43(3) Pg. ONLINEIDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731> Praveen Pabba

Revision TRANDOLAPRIL PF 43(3) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Procedure 1: Residue on Ignition <281>, IMPURITIES/Procedure 2 Donald Min

Revision TRIHEXYPHENIDYL HYDROCHLORIDE ORAL SOLUTION PF 42(5) Pg. ONLINE

DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Sridevi Ramachandran

New TRIPTORELIN PAMOATE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C64H82N18O13 · C23H16O6, Chemical Info/1311.45 (free base), Chemical Info/6-d-Tryptophan-, 4,4&prime;-methylenebis[3-hydroxy-2-naphthalenecarboxylate] (salt);, Chemical Info/ 5-Oxo-l-prolyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosyl-d-tryptophyl-l-leucyl-l-arginyl-l-prolylglycine amide, 4,4\'-methylenebis[3-hydroxy-2-naphthoate] (salt)., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Amino Acid Analysis, IDENTIFICATION/C. HPLC, ASSAY/Procedure, OTHER COMPONENTS/Pamoic Acid Content, ??UNKNOWN??/Triptorelin-Related Impurities, ??UNKNOWN??/Acetic Acid, SPECIFIC TESTS/Water Determination <921>, Method I, 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 Pamoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Related Compound C RS Dale Schmidt

Revision TROPICAMIDE OPHTHALMIC SOLUTION PF 42(6) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tropicamide Related Compound A RS N-(Pyridin-4-ylmethyl)ethanamine.C8H12N2 136.19, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Tropicamide Related Compound B RS N-Ethyl-2-phenyl-N-(pyridin-4-ylmethyl)acrylamide.C17H18N2O 266.34, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tropicamide Related Compound C RS 3-Hydroxy-2-phenylpropionic acid.C9H10O3 166.17, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tropicamide Related Compound D RS 2-Phenylacetic acid.C8H8O2 136.15 Ramanujam Prasad

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

Revision HYDROGENATED VEGETABLE OIL PF 43(2) Pg. ONLINEDEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ADDITIONAL REQUIREMENTS/Labeling Hong Wang

Revision VERAPAMIL HYDROCHLORIDE INJECTION PF 43(3) Pg. ONLINE

IDENTIFICATION/Identification-Organic Nitrogenous Bases <181>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Verapamil Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Verapamil Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Verapamil Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Verapamil Related Compound F RS Donald Min

Revision MICROCRYSTALLINE WAX PF 43(2) Pg. ONLINE

Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F> or <197A>, IDENTIFICATION/B. Melting Range or Temperature <741>,Procedures, Procedure for Class III, IMPURITIES/Residue on Ignition <281>, SPECIFIC TESTS/Melting Range or Temperature, Class III <741>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang

Revision WHITE WAX PF 42(2) Pg. ONLINE

Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F> or <197A>, IDENTIFICATION/B. Ultraviolet Absorption, SPECIFIC TESTS/Saponification Cloud Test, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class II, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Ester Value, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang

Revision YELLOW WAX PF 42(2) Pg. ONLINE

Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F> or <197A>, IDENTIFICATION/B. Ultraviolet Absorption, SPECIFIC TESTS/Saponification Cloud Test, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class II, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Ester Value, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Hong Wang

New ZINC SULFATE COMPOUNDED INJECTION PF 41(2) Pg. ONLINE

DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Particulate Matter in Injections <788>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Zinc Sulfate RS Jeanne Sun

Revision ZIPRASIDONE HYDROCHLORIDE PF 42(1) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K> <197>, ASSAY/Procedure, IMPURITIES/Limit of Early-Eluting Impurities, IMPURITIES/Limit of Late-Eluting Impurities, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ziprasidone Related Compound F RS Sridevi Ramachandran