Compendial Deferrals for USP42-NF37

Category Monograph Title Monograph Section Scientific Liaison

{Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent}, {Flavors and Fragrance} Neohesperidin Revision EXCIPIENTS (USP and NF), LISTED BY CATEGORY PF 42(2) Pg. ONLINE Dihydrochalcone NF, {Sweetening Agent} Neohesperidin Dihydrochalcone NF Hong Wang Revision GENERAL NOTICES TO USP-NF PF 44(1) Pg. ONLINE 2. OFFICIAL STATUS AND LEGAL RECOGNITION Jessica Simpson

Climbazole, Ropivacaine, Iscotrizinol, Trientine Hydrochloride, Sodium Lauroyl Sarcosinate, Epinastine Hydrochloride, Guanidine Hydrochloride, Desvenlafaxine, Desvenlafaxine Fumarate, Desvenlafaxine Succinate, Gadobutrol, Rotigotine, Benzphetamine Hydrochloride, Deferasirox, Eletriptan Hydrobromide, Milnacipran Revision DESCRIPTION AND SOLUBILITY PF 43(4) Pg. ONLINE Hydrochloride, Neohesperidin Dihydrochalcone Sujatha Ramakrishna

Title, INTRODUCTION/Introduction, PROCEDURE/Identification, PROCEDURE/Enumeration, PERFORMANCE TESTS/, CONTAMINANTS/Introduction, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Storage, ADDITIONAL New <64> PROBIOTIC TESTS PF 43(2) Pg. ONLINE REQUIREMENTS/Labeling, ??UNKNOWN??/Introduction Seong Jae Yoo ??UNKNOWN??/Rabbit Blood Sugar Method-Quantitative, ??UNKNOWN??/In Vivo Bioidentity Test, ??UNKNOWN??/In Vitro Cell-Based Bioidentity Test for Insulin Glargine Revision <121> INSULIN ASSAYS PF 43(4) Pg. ONLINE and Insulin Lispro Diane McCarthy

Title, INTRODUCTION, IDENTIFICATION OF IMPURITIES AND DEGRADATION PRODUCTS, ANALYTICAL PROCEDURES FOR IMPURITIES AND DEGRADATION PRODUCTS, REPORTING IMPURITIES AND DEGRADATION PRODUCTS, SETTING ACCEPTANCE CRITERIA FOR IMPURITIES AND DEGRADATION PRODUCTS, <476> CONTROL OF ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG QUALIFICATION OF IMPURITIES AND DEGRADATION PRODUCTS, ORGANIC Revision PRODUCTS PF 43(6) Pg. ONLINE IMPURITIES IN DRUG SUBSTANCES, ORGANIC IMPURITIES IN DRUG PRODUCTS Antonio Hernandez-Cardoso Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards New <509> RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE <11> Elena Curti

TABLE OF CONTENTS, INTRODUCTION, A. DELIVERED-DOSE UNIFORMITYDELIVERED CONTENT UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS <601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND AND SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION-INHALATION Revision POWDERS--PERFORMANCE QUALITY TESTS PF 42(6) Pg. ONLINE AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi DEFINITIONS, SYSTEM SUITABILITY, ADJUSTMENT OF CHROMATOGRAPHIC New <621> CHROMATOGRAPHY PF 43(5) Pg. ONLINE CONDITIONS, QUANTIFICATION Horacio Pappa

INTRODUCTION, OSMOTIC PRESSUREBACKGROUND, OSMOLALITYOPERATION AND Revision <785> OSMOLALITY AND OSMOLARITY PF 43(5) Pg. ONLINE CALIBRATION OF OSMOMETER, OSMOLARITY, MEASUREMENT OF OSMOLALITY Margareth Marques 1. INTRODUCTION, 2. QUALIFICATION OF NIR SPECTROMETERS, 3. PROCEDURE, 4. VALIDATION AND VERIFICATION, 1. INTRODUCTION, USP REFERENCE STANDARDS New <856> NEAR-INFRARED SPECTROSCOPY PF 43(4) Pg. ONLINE <11> Kahkashan Zaidi

INTRODUCTION, QUALIFICATION OF UV-VIS SPECTROMETERS, PROCEDURE, Revision <857> ULTRAVIOLET-VISIBLE SPECTROSCOPY PF 43(5) Pg. ONLINE VALIDATION AND VERIFICATIONVERIFICATION AND VALIDATION Margareth Marques Title, Introduction, QUALIFICATION OF RAMAN SPECTROMETERS, PROCEDURE, New <858> RAMAN SPECTROSCOPY PF 43(4) Pg. ONLINE VALIDATION AND VERIFICATION, VERIFICATION, Title Kahkashan Zaidi <915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY New PENETROMETRY PF 43(2) Pg. ONLINE Title, INTRODUCTION, PROCEDURE, GLOSSARY Antonio Hernandez-Cardoso INTRODUCTION, REGULATORY CONSIDERATIONS, IMPACT OF ANCILLARY MATERIAL QUALITY ON PRODUCT QUALITY, QUALIFICATION OF ANCILLARY MATERIALS, RISK <1043> ANCILLARY MATERIALS FOR CELL, GENE AND TISSUE ENGINEERED CLASSIFICATIONMANAGEMENT, PERFORMANCE TESTING, ANCILLARY MATERIALS Revision PRODUCTS PF 43(4) Pg. ONLINE RESIDUAL LEVELRESIDUAL ASSESSMENT AND REMOVAL, CONCLUSION, APPENDIX Fouad Atouf <1057> BIOTECHNOLOGY-DERIVED ARTICLES -- TOTAL PROTEIN ASSAY PF 44(1) Pg. Introduction, INTRODUCTION, SAMPLE EXTRACTION METHODS FOR TOTAL PROTEIN Revision ONLINE ASSAYS, TOTAL PROTEIN MEASUREMENT PROCEDURES Elena Curti

INTRODUCTION, DRUG SUBSTANCE, DRUG PRODUCT, ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS, ORGANIC IMPURITIES DECISION TREE, TERMINOLOGY ASSOCIATED WITH ORGANIC IMPURITIES USED IN DRUG SUBSTANCE <1086> IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 43(6) Pg. AND DRUG PRODUCT MONOGRAPHS, APPENDIX 1:GLOSSARY, APPENDIX 2: Revision ONLINE ADDITIONAL SOURCES OF INFORMATION AND GUIDANCE Antonio Hernandez-Cardoso

1. THEORY, 2. TRANSMISSION, REFLECTION, AND TRANSFLECTION MODES, 3. FACTORS THAT AFFECT NIR SPECTRA, 4. PRETREATMENT OF NIR SPECTRAL DATA, 5. INSTRUMENTATION, 6. APPLICATIONS, INTRODUCTION, INSTRUMENTATION, METHOD VALIDATION, GLOSSARY, *No Head*, 1. THEORY, 7. PROCEDURE VALIDATION, 8. Revision <1119> NEAR-INFRARED SPECTROSCOPY PF 43(4) Pg. ONLINE APPENDIX: GLOSSARY Kahkashan Zaidi

Title, Introduction, INTRODUCTION, THEORY, QUALITATIVE AND QUANTITATIVE RAMAN MEASUREMENTS, FACTORS AFFECTING QUANTIFICATION, SAMPLING FACTORS, APPARATUS, QUALIFICATION AND VERIFICATION OF RAMAN SPECTROMETERS, SPECIALIZED TECHNIQUES, METHOD VALIDATION, PROCEDURE VALIDATION, DEFINITION OF TERMS AND SYMBOLS, CALIBRATION, FACTORS THAT Revision <1120> RAMAN SPECTROSCOPY PF 40(6) Pg. ONLINE AFFECT MEASUREMENT PERFORMANCE Kahkashan Zaidi

New <1912> MEASUREMENT OF HARDNESS OF SEMISOLIDS PF 43(2) Pg. ONLINE Title, BACKGROUND, EXPERIMENTAL METHODS, GLOSSARY, REFERENCES Antonio Hernandez-Cardoso IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, Revision ACETAMINOPHEN TABLETS PF 42(3) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure Clydewyn Anthony

IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS PF 43(5) Pg. ONLINE Standards <11>/USP Codeine N-Oxide RS Wei Yang IMPURITIES/Silver-Reducing Substances, IMPURITIES/Ordinary Impurities <466>, Revision ACETAZOLAMIDE PF 43(4) Pg. ONLINE IMPURITIES/Organic Impurities Feiwen Mao New AFLATOXIN G1 PF 44(1) Pg. ONLINE Aflatoxin G1, Maria Monagas New AFLATOXIN B2 PF 44(1) Pg. ONLINE Aflatoxin B2, Maria Monagas New AFLATOXIN B1 PF 44(1) Pg. ONLINE Aflatoxin B1, Maria Monagas New AFLATOXIN G2 PF 44(1) Pg. ONLINE Aflatoxin G2, Maria Monagas Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Alcohol Content, PERFORMANCE TESTS/Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders-Performance Quality Tests <601>, C. Aerodynamic Size Distribution- Inhalation Aerosols, Sprays, and Powders, PERFORMANCE TESTS/Delivered-Dose Uniformity (Between Units), PERFORMANCE TESTS/Delivered-Dose Uniformity (Within Unit), 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 Albuterol Sulfate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol Determination-Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New ALBUTEROL INHALATION AEROSOL PF 44(1) Pg. ONLINE <11>/USP Levalbuterol Related Compound D RS Ravi Ravichandran ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Revision ALCLOMETASONE DIPROPIONATE CREAM PF 43(1) Pg. ONLINE Dipropionate RS Mary Koleck ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Revision ALCLOMETASONE DIPROPIONATE OINTMENT PF 43(1) Pg. ONLINE Dipropionate RS Mary Koleck

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 New ALOSETRON HYDROCHLORIDE PF 43(2) Pg. ONLINE Alosetron Related Compound A RS Andrea Carney

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 New ALOSETRON TABLETS PF 43(2) Pg. ONLINE Compound A RS Andrea Carney

DEFINITION/Introduction, IDENTIFICATION/<197S>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Clarity and Color of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amantadine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Revision AMANTADINE HYDROCHLORIDE PF 43(4) Pg. ONLINE Reference Standards <11>/USP Amantadine Related Compound B RS Shankari Shivaprasad IDENTIFICATION/A.Infrared Absorption <197S> <197>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Revision AMANTADINE HYDROCHLORIDE CAPSULES PF 43(4) Pg. ONLINE Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ Shankari Shivaprasad IDENTIFICATION/A. Infrared Absorption <197S><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amantadine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amantadine Related Compound B Revision AMANTADINE HYDROCHLORIDE ORAL SOLUTION PF 43(4) Pg. ONLINE RS Shankari Shivaprasad ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound H Revision AMOXICILLIN FOR ORAL SUSPENSION PF 42(6) Pg. ONLINE RS Ramanujam Prasad ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ampicillin Revision AMPICILLIN AND SULBACTAM FOR INJECTION PF 44(1) Pg. ONLINE System Suitability Mixture RS Ramanujam Prasad

Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Procedure, SPECIFIC TESTS/Fats and Fixed Oils <401>, Peroxide Value, SPECIFIC TESTS/Water Determination <921>, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Annatto New ANNATTO SEED TOCOTRIENOLS EXTRACT PF 42(3) Pg. ONLINE Seed Tocotrienols Extract RS Huy Dinh

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197K> or <197A>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Substances Insoluble in Sodium Carbonate TS, ADDITIONAL Revision ASPIRIN PF 41(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid RS Clydewyn Anthony

IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, ASSAY/Procedure, Revision ATOMOXETINE CAPSULES PF 44(1) Pg. ONLINE PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Heather Joyce

Title, Chemical Info/Chemical Structure, Chemical Info/C8H12N4O5, Chemical Info/244.20, Chemical Info/1,3,5-Triazin-2(1H)-one, 4-amino-1-β-d-ribofuranosyl- ;, Chemical Info/4-Amino-1-β-d-ribofuranosyl-s-triazin-2(1H)-one, 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 1-β-d-Ribofuranosyl-3- guanylurea, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azacitidine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azacitidine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Azacitidine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference New AZACITIDINE PF 43(5) Pg. ONLINE Standards <11>/USP Azacitidine Related Compound C RS Feiwen Mao 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 Revision AZATHIOPRINE TABLETS PF 43(3) Pg. ONLINE <11>/USP Mercaptopurine RS Feiwen Mao

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 New AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION PF 43(3) Pg. ONLINE <11>/USP Azelastine Related Compound F RS Mary Koleck

Chemical Info/Chemical NameChemical Info/Chemical StructureChemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Revision BENZONATATE PF 44(1) Pg. ONLINE Reference Standards <11>/USP Tetracaine Related Compound B RS Wei Yang

Title, Chemical Info/Chemical Structure, Chemical Info/C17H21N·HCl, Chemical Info/275.82, Chemical Info/(+)-N-Benzyl-N,α-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 New BENZPHETAMINE HYDROCHLORIDE PF 43(3) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Benzyl Chloride RS Wei Yang

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 New BENZPHETAMINE HYDROCHLORIDE TABLETS PF 43(3) Pg. ONLINE <11>/USP Methamphetamine Hydrochloride RS Wei Yang IDENTIFICATION/Infrared Absorption <197M>, IDENTIFICATION/Thin-Layer Chromatographic Identification Test <201>, ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Acetate Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Acetate Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Revision BETAMETHASONE ACETATE PF 42(5) Pg. ONLINE Standards <11>/USP Dexamethasone Acetate RS Mary Koleck

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

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Dipropionate Revision BETAMETHASONE DIPROPIONATE LOTION PF 42(6) Pg. ONLINE Related Compound C RS Mary Koleck IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betaxolol Related Compound A Revision BETAXOLOL HYDROCHLORIDE PF 43(6) Pg. ONLINE RS Feiwen Mao

IDENTIFICATION/B, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision BETAXOLOL TABLETS PF 43(6) Pg. ONLINE Standards <11>/USP Betaxolol Related Compound A RS Feiwen Mao

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavonoids, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bitter Orange Fruit Flavonoids Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naringin RS, ADDITIONAL New BITTER ORANGE FRUIT FLAVONOIDS DRY EXTRACT PF 44(1) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Neohesperidin RS Maria Monagas

IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Revision BROMOCRIPTINE MESYLATE CAPSULES PF 43(6) Pg. ONLINE IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Mary Koleck Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New BUDESONIDE DELAYED-RELEASE CAPSULES PF 42(5) Pg. ONLINE <11>/USP Budesonide Related Compound L RS Mary Koleck

IDENTIFICATION/A. Infrared Absorption <197M><197>, IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Butyl 3- Revision BUMETANIDE PF 44(1) Pg. ONLINE (butylamino)-4-phenoxy-5-sulfamoylbenzoate RS Edith Chang

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bumetanide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Revision BUMETANIDE INJECTION PF 44(1) Pg. ONLINE Standards <11>/USP Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate RS Edith Chang

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Revision BUMETANIDE TABLETS PF 43(6) Pg. ONLINE Standards <11>/USP Bumetanide Related Compound B RS Edith Chang IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Color and Clarity, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Particulate Matter in Injections <788>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision CAFFEINE CITRATE INJECTION PF 43(6) Pg. ONLINE Theophylline RS Heather Joyce Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Isopropyl Alcohol Content, 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 Calcipotriene RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Calcipotriene Related Compound New CALCIPOTRIENE TOPICAL SOLUTION PF 43(6) Pg. ONLINE C RS Feiwen Mao

IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Captopril Disulfide, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Captopril Revision CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLETS PF 43(4) Pg. ONLINE Disulfide RS Edith Chang IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Revision CARBIDOPA AND LEVODOPA ORALLY DISINTEGRATING TABLETS PF 44(1) Pg. ONLINE IMPURITIES/Organic Impurities Heather Joyce IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ADDITIONAL REQUIREMENTS/USP Reference Revision LOW-SUBSTITUTED CARBOXYMETHYLCELLULOSE SODIUM PF 43(6) Pg. ONLINE Standards <11> Tong Liu

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms Revision CEFIXIME PF 44(1) Pg. ONLINE <62>, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation Slavica Shane Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, 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 New CEFIXIME CAPSULES PF 44(1) Pg. ONLINE Standards <11>/USP Cefixime RS Slavica Shane

IDENTIFICATION/ A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Revision CEFIXIME FOR ORAL SUSPENSION PF 44(1) Pg. ONLINE Enumeration Tests <61> and Tests for Specified Microorganisms <62> Slavica Shane

IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Revision CEFIXIME TABLETS PF 44(1) Pg. ONLINE Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Slavica Shane

IDENTIFICATION/B. Identification Tests-General, Sodium <191>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling <7>, Labels and Labeling for Injectable Products, Revision CEFOTETAN FOR INJECTION PF 43(6) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Slavica Shane IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision CEFOTETAN DISODIUM PF 43(6) Pg. ONLINE <11>/USP Endotoxin RS Slavica Shane

ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, IMPURITIES/Limit of Celecoxib Related Compound D, IMPURITIES/Limits of 4-Hydrazinylbenzenesulfonamide Hydrochloride and Sulfanilamide, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Celecoxib Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4- Hydrazinylbenzenesulfonamide Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Revision CELECOXIB PF 43(6) Pg. ONLINE Reference Standards <11>/USP Sulfanilamide RS Wei Yang

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 New CELECOXIB CAPSULES PF 43(3) Pg. ONLINE RS Wei Yang ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, IMPURITIES/Procedure 2, ADDITIONAL Revision CEPHALEXIN PF 43(6) Pg. ONLINE REQUIREMENTS/Labeling Slavica Shane ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, Revision CEPHALEXIN CAPSULES PF 43(6) Pg. ONLINE ADDITIONAL REQUIREMENTS/Labeling Slavica Shane Revision CEPHALEXIN FOR ORAL SUSPENSION PF 43(6) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Slavica Shane New CHELATING ION EXCHANGE RESIN PF 41(3) Pg. ONLINE Chelating Ion-Exchange Resin Trish Li

IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/C. Thin-Layer Chromatographic Identification Test <201>, ASSAY/Procedure, IMPURITIES/Limit of p- Chloroaniline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorhexidine System Suitability Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Potassium Revision CHLORHEXIDINE GLUCONATE TOPICAL GEL PF 43(6) Pg. ONLINE Gluconate RS Sujatha Ramakrishna New CHLOROMETHYLNITROIMIDAZOLE PF 43(3) Pg. ONLINE Chloromethylnitroimidazole Sridevi Ramachandran

IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, OTHER COMPONENTS/Chlorine Content, IMPURITIES/Chromatographic Purity, IMPURITIES/Limit of Chlorzoxazone Related Compound A, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Revision CHLORZOXAZONE PF 43(4) Pg. ONLINE Temperature <741> Heather Joyce

IDENTIFICATION/A. Ultraviolet Absorption, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Chlorzoxazone Related Compound A, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision CHLORZOXAZONE TABLETS PF 43(4) Pg. ONLINE Chlorzoxazone Related Compound A RS Heather Joyce

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

Title, Chemical Info/Chemical Structure, Chemical Info/C15H17ClN2O2, Chemical Info/292.76, Chemical Info/1-(p-Chlorophenoxy)-1-imidazol-1-yl-3,3-dimethyl-2- butanone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL New CLIMBAZOLE PF 43(4) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Climbazole RS Sujatha Ramakrishna IDENTIFICATION/Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Revision CLOMIPHENE CITRATE TABLETS PF 43(4) Pg. ONLINE IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Mary Koleck

DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities: Procedure for the Sterile Powder Formulation, IMPURITIES/Organic Impurities: Procedure for the Lyophilized Formulation, IMPURITIES/Limit of Cyclophosphamide Related Compound C: Procedure for the Lyophilized Formulation, SPECIFIC TESTS/Limit of Chloride for the Lyophilized Formulation, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclophosphamide Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Revision CYCLOPHOSPHAMIDE FOR INJECTION PF 43(1) Pg. ONLINE Reference Standards <11>/USP Cyclophosphamide Related Compound D RS Feiwen Mao Revision CYPROHEPTADINE HYDROCHLORIDE TABLETS PF 43(1) Pg. ONLINE IMPURITIES/Organic Impurities Mary Koleck

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 New DEFERASIROX PF 43(3) Pg. ONLINE Suitability Mixture RS Andrea Carney

Title, Chemical Info/Chemical Structure, Chemical Info/C16H25NO2, Chemical Info/263.38, Chemical Info/4-[2-(Dimethylamino)-1-(1- hydroxycyclohexyl)ethyl]phenol;, Chemical Info/1-[2-(Dimethylamino)-1-(4- hydroxyphenyl)ethyl]cyclohexanol hydrogen, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, 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 Desvenlafaxine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Desvenlafaxine Related Compound A RS 4-[1-(Cyclohex-1-en-1- yl)-2-(dimethylamino)ethyl]phenol.C16H23NO245.37, ADDITIONAL New DESVENLAFAXINE PF 43(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/ USP Venlafaxine Hydrochloride RS Heather Joyce Title, Chemical Info/Chemical Structure, Chemical Info/C16H25NO2·C4H4O4·H2O, Chemical Info/397.46, Chemical Info/C16H25NO2·C4H4O4, Chemical Info/379.45, Chemical Info/trans-Butenedioic acid, compound with 4-[2-(dimethylamino)-1-(1- hydroxycyclohexyl)ethyl]phenol (1:1), monohydrate;, Chemical Info/1-[2- (Dimethylamino)-1-(4-hydroxyphenyl)ethyl]cyclohexanol trans-butenedioate monohydrate, Chemical Info/CAS, Chemical Info/Anhydrous, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Desvenlafaxine Fumarate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Desvenlafaxine Related Compound B RS 4-[1-(1-Hydroxycyclohexyl)-2- New DESVENLAFAXINE FUMARATE PF 43(5) Pg. ONLINE (methylamino)ethyl]phenol.C15H23NO2249.35 Heather Joyce

Title, Chemical Info/Chemical Structure, Chemical Info/C16H25NO2·C4H6O4·H2O, Chemical Info/399.48, Chemical Info/C16H25NO2·C4H6O4, Chemical Info/381.47, Chemical Info/ Butanedioic acid, compound with 4-[2-(dimethylamino)-1-(1- hydroxycyclohexyl)ethyl]phenol (1:1), monohydrate;, Chemical Info/ 1-[2- (Dimethylamino)-1-(4-hydroxyphenyl)ethyl]cyclohexanol hydrogen butanedioate monohydrate, Chemical Info/CAS, Chemical Info/Anhydrous, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Desvenlafaxine Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Desvenlafaxine Related Compound B RS 4-[1-(1- New DESVENLAFAXINE SUCCINATE PF 43(5) Pg. ONLINE Hydroxycyclohexyl)-2-(methylamino)ethyl]phenol.C15H23NO2249.35 Heather Joyce

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY, ASSAY/Procedure, PERFORMANCE TESTS, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desvenlafaxine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desvenlafaxine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desvenlafaxine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desvenlafaxine Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New DESVENLAFAXINE EXTENDED-RELEASE TABLETS PF 44(1) Pg. ONLINE <11>/USP Venlafaxine Hydrochloride RS Heather Joyce

IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Desoximetasone RS, ADDITIONAL Revision DEXAMETHASONE PF 42(4) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Acetate RS Mary Koleck IDENTIFICATION/Thin-Layer Chromatography, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Revision DEXAMETHASONE ELIXIR PF 43(6) Pg. ONLINE Standards <11>/USP Betamethasone RS Mary Koleck

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylparaben RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prednisolone RS, ADDITIONAL Revision DEXAMETHASONE ORAL SOLUTION PF 43(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Propylparaben RS Mary Koleck

IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Sodium Phosphate RS, ADDITIONAL Revision DEXAMETHASONE SODIUM PHOSPHATE INJECTION PF 43(3) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Mary Koleck

IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Revision DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION PF 43(6) Pg. ONLINE Reference Standards <11>/USP Betamethasone Sodium Phosphate RS Mary Koleck

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Limit of Phenolic Compounds, IMPURITIES/Limit of N,N- Dimethylaniline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Revision DEXTROMETHORPHAN PF 43(5) Pg. ONLINE Reference Standards <11>/USP Dextromethorphan Related Compound C RS Clydewyn Anthony

IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Limit of Phenolic Compounds, IMPURITIES/Limit of N,N-Dimethylaniline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision DEXTROMETHORPHAN HYDROBROMIDE PF 43(5) Pg. ONLINE Standards <11>/USP Dextromethorphan Related Compound C RS Clydewyn Anthony

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Dimethyl Sulfoxide (if present), OTHER COMPONENTS/Content of Ethanol (if present), IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference New DICLOFENAC SODIUM TOPICAL SOLUTION PF 44(1) Pg. ONLINE Standards <11>/USP Diclofenac Sodium RS Wei Yang

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Readily Carbonizable Substances Test <271>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Dicyclomine Related Compound A, SPECIFIC TESTS/Melting Range or Temperature, Class I <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Revision DICYCLOMINE HYDROCHLORIDE PF 43(6) Pg. ONLINE Compound A RS Behnaz Almasi

ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision DICYCLOMINE HYDROCHLORIDE CAPSULES PF 43(6) Pg. ONLINE Dicyclomine Related Compound A RS Behnaz Almasi ASSAY/Procedure, IMPURITIES/Limit of Dicyclomine Related Compound A, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A Revision DICYCLOMINE HYDROCHLORIDE INJECTION PF 43(6) Pg. ONLINE RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Behnaz Almasi

ASSAY/Procedure, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Revision DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION PF 43(6) Pg. ONLINE Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi

ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision DICYCLOMINE HYDROCHLORIDE TABLETS PF 43(6) Pg. ONLINE Dicyclomine Related Compound A RS Behnaz Almasi Revision DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES PF 43(5) Pg. ONLINE PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Clydewyn Anthony

IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Related Compound B RS, ADDITIONAL Revision DIPHENHYDRAMINE HYDROCHLORIDE ORAL SOLUTION PF 43(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine N-Oxide RS Clydewyn Anthony

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Immediate-Release Dosage Forms, Procedure for a Pooled Sample, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP New DIPHENHYDRAMINE HYDROCHLORIDE TABLETS PF 43(4) Pg. ONLINE Reference Standards <11>/USP Diphenhydramine N-Oxide RS Clydewyn Anthony DIPHENHYDRAMINE AND PHENYLEPHRINE HYDROCHLORIDES TABLETS PF 43(5) Pg. Revision ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Clydewyn Anthony

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP New DIPHENHYDRAMINE HYDROCHLORIDE ORAL POWDER PF 43(5) Pg. ONLINE Reference Standards <11>/USP Diphenhydramine N-Oxide RS Clydewyn Anthony Chemical Info/296.54296.52, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/<291>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class Revision DISULFIRAM PF 43(6) Pg. ONLINE I <741> Heather Joyce IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Color of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dobutamine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dopamine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Revision DOBUTAMINE HYDROCHLORIDE PF 43(6) Pg. ONLINE Standards <11>/USP Raspberry Ketone RS Edith Chang

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, 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/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Volatile Oil Determination, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination <921>, Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Angelica sinensis Root Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Z-Ligustilide RS, ADDITIONAL REQUIREMENTS/USP New DONG QUAI ROOT PF 43(5) Pg. ONLINE Reference Standards <11>/USP Senkyunolide A RS Cuiying Ma Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, 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/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Volatile Oil Determination, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination <921>, Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Angelica sinensis Root Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Z-Ligustilide RS, ADDITIONAL REQUIREMENTS/USP New DONG QUAI ROOT POWDER PF 43(5) Pg. ONLINE Reference Standards <11>/USP Senkyunolide A RS Cuiying Ma

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- New ELETRIPTAN HYDROBROMIDE PF 43(3) Pg. ONLINE Toluenesulfonate RS Heather Joyce

IDENTIFICATION/A.Infrared Absorption <197K><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL Revision EPHEDRINE PF 43(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Pseudoephedrine Sulfate RS Clydewyn Anthony Chemical Info/Chemical Structure, IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision EPHEDRINE SULFATE PF 43(5) Pg. ONLINE <11>/USP Pseudoephedrine Sulfate RS Clydewyn Anthony 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 New EPINASTINE HYDROCHLORIDE PF 43(2) Pg. ONLINE Epinastine Related Compound A RS Gerald Hsu

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Adrenalone, IMPURITIES/Limit of Norepinephrine, IMPURITIES/Enantiomeric Purity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Adrenalone Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norepinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision EPINEPHRINE PF 42(6) Pg. ONLINE <11>/USP Racepinephrine Hydrochloride RS Sujatha Ramakrishna

Title, Chemical Info/Chemical Structure, Chemical Info/C1982H3054N560O618S28, Chemical Info/INS: (The chemical formula includes the γ-carboxylations and modification of D (Asp) in position 63, and does not include the glycosylations.), Chemical Info/≊50,000 (The molecular weight includes the glycosylation.), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Peptide Mapping, ASSAY/Concentration of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Gla-Domainless Eptacog Alfa (γ-Carboxylation), IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, IMPURITIES/Non-Activated Factor VII (Single Chain), SPECIFIC TESTS/Glycan Analysis, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa for Bioassay RS, {Title} Activated, ASSAY/Concentration of Eptacog Alfa Activated, IMPURITIES/Gla-Domainless Eptacog Alfa Activated (γ- New EPTACOG ALFA ACTIVATED PF 41(3) Pg. ONLINE Carboxylation) Kevin Carrick Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Content of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, SPECIFIC TESTS/Water Determination <921>, Method 1c, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, Test for Sterility of the Product to Be Examined, Membrane Filtration, SPECIFIC TESTS/Constituted Solution, ADDITIONAL REQUIREMENTS/Packaging and Storage Requirements <659>, Injection Packaging, Sterile solids packaging, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Coagulation Factor VIIa for Bioassay RS, {Title} Activated, New EPTACOG ALFA ACTIVATED FOR INJECTION PF 41(3) Pg. ONLINE ASSAY/Content of Eptacog Alfa Activated Kevin Carrick Revision Eriochrome Black T PF 43(5) Pg. ONLINE Eriochrome Black T Margareth Marques

Title, Chemical Info/Chemical Structure, Chemical Info/C22H24N3NaO7S, Chemical Info/497.50, Chemical Info/1-Azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 3-[[5-[[(3- carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo- , monosodium salt, [4R-[3(3S*,5S*), 4α,5β,6β(R*)]]-;, Chemical Info/(4R,5S,6S)-3-[[(3S,5S)-5-[(m-Carboxyphenyl)carbamoyl]-3-pyrrolidinyl]thio]-6- [(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, monosodium salt, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference New ERTAPENEM SODIUM PF 44(1) Pg. ONLINE Standards <11>/USP Ertapenem Sodium RS Ramanujam Prasad

Title, DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP New ESTRIOL COMPOUNDED VAGINAL CREAM PF 42(5) Pg. ONLINE Reference Standards <11>/USP Estriol RS Jeanne Sun

IDENTIFICATION/A. Infrared Absorption <197K><197>, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Aminobutanol, Revision ETHAMBUTOL HYDROCHLORIDE PF 43(6) Pg. ONLINE SPECIFIC TESTS/Limit of Total Stereoisomers Shankari Shivaprasad Omission ETHOTOIN PF 43(3) Pg. ONLINE Entire document Heather Joyce Omission ETHOTOIN TABLETS PF 43(3) Pg. ONLINE Entire document Heather Joyce Title, Chemical Info/Chemical Structure, Chemical Info/C53H83NO14, Chemical Info/958.22, Chemical Info/(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy- 12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]- 19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4- azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone;, Chemical Info/(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)- 9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3- [(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21- dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1- c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Alcohol, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Sirolimus, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Organisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Everolimus RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Everolimus System Suitability Mixture RS, ADDITIONAL New EVEROLIMUS PF 42(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Sirolimus RS Morgan Puderbaugh

Title, DEFINITION/Introduction, IDENTIFICATION/A.Infrared Absorption <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/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Famciclovir RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Famciclovir Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Famciclovir Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Famciclovir System Suitability New FAMCICLOVIR TABLETS PF 44(1) Pg. ONLINE Mixture RS Shankari Shivaprasad

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

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Fentanyl Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Fentanyl Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Fentanyl Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fentanyl Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Revision FENTANYL PF 44(1) Pg. ONLINE Reference Standards <11>/USP Fentanyl Related Compound G RS Wei Yang Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Deliverable Volume <698>, 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/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fexofenadine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fexofenadine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fexofenadine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fexofenadine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New FEXOFENADINE HYDROCHLORIDE ORAL SUSPENSION PF 43(6) Pg. ONLINE <11>/USP Propylparaben RS Gerald Hsu Revision FLUOXETINE HYDROCHLORIDE PF 43(6) Pg. ONLINE IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities Heather Joyce Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluvastatin Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluvastatin for New FLUVASTATIN EXTENDED-RELEASE TABLETS PF 42(4) Pg. ONLINE System Suitability RS Sujatha Ramakrishna

IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Test 2, ADDITIONAL Revision FLUVOXAMINE MALEATE TABLETS PF 42(5) Pg. ONLINE REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Heather Joyce

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Maleic Acid and Malic Acid, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Glacial Acetic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lactic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Malic Acid RS, Revision FUMARIC ACID PF 43(5) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Succinic Acid RS Galina Holloway

Title, Chemical Info/Chemical Structure, Chemical Info/C18H31GdN4O9·H20, Chemical Info/622.73, Chemical Info/Gadolinium, [10-[2-(hydroxy-&kgr;O)-3-hydroxy-1- (hydroxymethyl)propyl]-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-)-&kgr;N1, &kgr;N4, &kgr;N7, &kgr;N10,&kgr;O1, &kgr;O4, &kgr;O7]-, monohyrdate, [SA-8- 1425362′5′-(R*,S*)]-;, Chemical Info/ [10-[(2RS,3SR)-1,2,3- Trihydroxybutan-2-yl]-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-)]gadolinium monohydrate, Chemical Info/CAS, Chemical Info/Anhydrous, Chemical Info/604.71, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Free Gadolinium, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Gadobutrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Gadobutrol System Suitability New GADOBUTROL PF 43(5) Pg. ONLINE Mixture RS Ravi Ravichandran IDENTIFICATION/B., SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Revision HARD GELATIN CAPSULE SHELL PF 43(6) Pg. ONLINE Specified Microorganisms <62> Margareth Marques IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., Revision GENTAMICIN SULFATE PF 43(3) Pg. ONLINE IMPURITIES/Organic Impurities, SPECIFIC TESTS/Content of Gentamicins Slavica Shane

IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, Title, Chemical Info/Chemical Structure, Chemical Info/CH5N3·HCl, Chemical Info/95.53, Chemical Info/Guanidine, hydrochloride (1:1);, Chemical Info/Guanidine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Chloride and Sulfate <221>, Sulfate, IMPURITIES/Limit of Nitrate, IMPURITIES/Limit of Cyanide, IMPURITIES/Residue on Ignition <281>, SPECIFIC TESTS/Acidity, SPECIFIC TESTS/Water-Insoluble Substances, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class 1, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New GUANIDINE HYDROCHLORIDE PF 43(4) Pg. ONLINE <11>/USP Guanidine Hydrochloride RS Galina Holloway

IDENTIFICATION/B., IMPURITIES/Related Compounds, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Alanine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Arginine RS, ADDITIONAL Revision HISTIDINE PF 43(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP l-Lysine Hydrochloride RS Fatkhulla Tadjimukhamedov

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, Revision HYDROMORPHONE HYDROCHLORIDE PF 44(1) Pg. ONLINE IMPURITIES/Introduction, IMPURITIES/Organic Impurities, Procedure 1 Wei Yang

Title, {Title} Hard, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Disintegration <701>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Revision HARD HYPROMELLOSE CAPSULE SHELL PF 44(1) Pg. ONLINE Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Margareth Marques

IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of 2-Chloroethylamine Hydrochloride, IMPURITIES/Chloroform-Insoluble Phosphorus, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound F RS, ADDITIONAL Revision IFOSFAMIDE PF 43(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Monoethanolamine RS Feiwen Mao

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision IFOSFAMIDE FOR INJECTION PF 43(6) Pg. ONLINE <11>/USP Monoethanolamine RS Feiwen Mao Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ifosfamide Related Compound C, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/ pH <791>, SPECIFIC TESTS/Color and Light Transmission, SPECIFIC TESTS/Osmolality and Osmolarity <785>, Osmolality, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ifosfamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New IFOSFAMIDE INJECTION PF 43(6) Pg. ONLINE <11>/USP Ifosfamide Related Compound C RS Feiwen Mao

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 Revision IMIPENEM PF 43(3) Pg. ONLINE Determination <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage Ramanujam Prasad IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Lactic Acid Content, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Inamrinone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Inamrinone Related Compound C Revision INAMRINONE INJECTION PF 44(1) Pg. ONLINE RS Edith Chang

Title, Chemical Info/Chemical Structure, Chemical Info/C44H59N7O5, Chemical Info/765.98, Chemical Info/Benzoic acid, 4,4′-[[6-[[4-[[(1,1- dimethylethyl)amino]carbonyl]phenyl]amino]-1,3,5-triazine-2,4-diyl]diimino]bis-, bis(2- ethylhexyl) ester;, Chemical Info/Bis(2-ethylhexyl) 4,4′-[(6-{[4-(tert- butylcarbamoyl)phenyl]amino}-1,3,5-triazine-2,4-diyl)diimino]dibenzoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethylhexyl Triazone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethylhexyl Triazone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethylhexyl Triazone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound G RS, ADDITIONAL REQUIREMENTS/USP New ISCOTRIZINOL PF 43(5) Pg. ONLINE Reference Standards <11>/USP Iscotrizinol Related Compound I RS Feiwen Mao 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 Itraconazole RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Itraconazole System Suitability New ITRACONAZOLE CAPSULES PF 43(6) Pg. ONLINE Mixture RS Shankari Shivaprasad Title, Chemical Info/Chemical Structure, Chemical Info/C8H20NO6P, Chemical Info/257.22, Chemical Info/Choline hydroxide, (R)-2,3-dihydroxypropyl hydrogen phosphate, inner salt;, Chemical Info/(R)-2,3-Dihydroxypropyl 2- (trimethylammonio)ethyl phosphate;, Chemical Info/l-α- Glycerylphosphorylcholine, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Chloride, Sulfate, Phosphate, and Acetate, IMPURITIES/Limit of Glycerol, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, 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/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Glycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-alpha-Glycerophosphorylethanolamine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-alpha-Glycerylphosphorylcholine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-alpha- Glycerylphosphorylcholine Solution RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP beta-Glycerylphosphorylcholine RS, ADDITIONAL New L-ALPHA-GLYCERYLPHOSPHORYLCHOLINE PF 43(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP l-Serine RS Huy Dinh New L113 PF 43(4) Pg. ONLINE L113- Michael Chang New L115 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex CarboPac PA100) Trish Li New L116 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex DNAPac PA100) Trish Li

Title, Chemical Info/Chemical Structure, Chemical Info/C13H18N2O3, Chemical Info/250.30, Chemical Info/Propanamide, 2-(acetylamino)-3-methoxy-N- (phenylmethyl)-, (2R)-;, Chemical Info/(+)-(2R)-2-(Acetylamino)-N-benzyl-3- methoxypropanamide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Lacosamide S-Enantiomer, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide S- Enantiomer RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New LACOSAMIDE PF 43(6) Pg. ONLINE Lacosamide Related Compound B RS Ren-Hwa Yeh

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound F New LACOSAMIDE INJECTION PF 43(6) Pg. ONLINE RS Ren-Hwa Yeh Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Deliverable Volume <698>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide New LACOSAMIDE ORAL SOLUTION PF 43(6) Pg. ONLINE Related Compound F RS Ren-Hwa Yeh

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 Lacosamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lacosamide New LACOSAMIDE TABLETS PF 43(6) Pg. ONLINE Related Compound F RS Ren-Hwa Yeh

Title, Chemical Info/Chemical Structure, Chemical Info/C12H22O11, Chemical Info/342.30, Chemical Info/d-Fructose, 4-O-β-d-galactopyranosyl-;, Chemical Info/4-O-β-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 New LACTULOSE PF 43(3) Pg. ONLINE Lactulose RS Andrea Carney

IDENTIFICATION/Infrared Absorption<197K>, IDENTIFICATION/B. Identification Tests- General <191> , Calcium, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of 5-(γ-Folinoyl)tetrahydrofolate, ADDITIONAL Revision LEUCOVORIN CALCIUM PF 42(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Folic Acid RS Feiwen Mao

Title, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Folic Acid RS, ADDITIONAL New LEUCOVORIN CALCIUM FOR INJECTION PF 42(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Leucovorin Calcium RS Feiwen Mao IDENTIFICATION/A. Infrared Absorption <197K>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision LIDOCAINE OINTMENT PF 43(6) Pg. ONLINE Standards <11>/USP Lidocaine Related Compound H RS Richard Nguyen IDENTIFICATION/A. Infrared Absorption <197>, ASSAY/Procedure, Revision LIDOCAINE HYDROCHLORIDE PF 43(3) Pg. ONLINE IMPURITIES/Organic Impurities Richard Nguyen IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision LIDOCAINE HYDROCHLORIDE JELLY PF 43(6) Pg. ONLINE Standards <11>/USP Lidocaine Related Compound H RS Richard Nguyen

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 Revision LIOTHYRONINE SODIUM PF 43(3) Pg. ONLINE Sodium RS Andrea Carney

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Revision LOPERAMIDE HYDROCHLORIDE PF 43(4) Pg. ONLINE Reference Standards <11>/USP Loperamide System Suitability Mixture RS Andrea Carney IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision LOVASTATIN TABLETS PF 44(1) Pg. ONLINE Standards <11>/USP Mevastatin RS Donald Min

DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Soluble Salts, IMPURITIES/Limit of Calcium, IMPURITIES/Limit of Lead, ADDITIONAL Revision MAGNESIUM HYDROXIDE PF 44(1) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Michael Chang IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Calcium, ADDITIONAL Revision MAGNESIUM OXIDE PF 43(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Michael Chang

IDENTIFICATION/B., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Revision MAGNESIUM OXIDE CAPSULES PF 43(6) Pg. ONLINE Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang

IDENTIFICATION/B., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Revision MAGNESIUM OXIDE TABLETS PF 43(6) Pg. ONLINE Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang

DEFINITION/Introduction, IDENTIFICATION/A. Procedure, IDENTIFICATION/C., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Fumaric Acid and Malic Acid, SPECIFIC TESTS/Color and Clarity of Solution, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Glacial Acetic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lactic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Malic Acid RS, ADDITIONAL REQUIREMENTS/USP Revision MALEIC ACID PF 43(5) Pg. ONLINE Reference Standards <11>/USP Succinic Acid RS Galina Holloway

DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate RSUSP Megestrol Acetate Related Compound C RS 6,13aβ-Dimethyl-3,17-dioxo- 13(17)a-homoandrosta-4,6-diene-13a-yl acetate.(C24H34O4386.52 ) USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene-17-yl acetate.(C24H32O4384.51 ) USP Megestrol Acetate Related Compound H RS Revision MEGESTROL ACETATE PF 42(6) Pg. ONLINE 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4398.54 ) Gerald Hsu IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Medroxyprogesterone Acetate RS USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene- 17-yl acetate.(C24H32O4 384.51 )USP Megestrol Acetate Related Compound H RS Revision MEGESTROL ACETATE TABLETS PF 42(6) Pg. ONLINE 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4 398.54 ) Gerald Hsu

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

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Metaraminol Related Compound B, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Content of Tartaric Acid, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metaraminol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metaraminol Related Compound B RS, ADDITIONAL Revision METARAMINOL BITARTRATE PF 44(1) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Metaraminol Enantiomer RS Donald Min

DEFINITION/Introduction, IDENTIFICATION/<197S>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Revision METHOHEXITAL PF 42(5) Pg. ONLINE Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Gerald Hsu IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Revision METHOHEXITAL SODIUM FOR INJECTION PF 42(5) Pg. ONLINE IMPURITIES/Organic Impurities Gerald Hsu ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Miconazole Related Revision MICONAZOLE PF 41(5) Pg. ONLINE Compound C RS Clydewyn Anthony 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- New MILNACIPRAN HYDROCHLORIDE PF 43(3) Pg. ONLINE carboxamide.C23H24N2O3376.46 Mary Koleck

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- New MILNACIPRAN HYDROCHLORIDE TABLETS PF 43(3) Pg. ONLINE azabicyclo[3.1.0]hexan-2-one.C11H11NO173.21 Mary Koleck

Chemical Info/Chemical Name Free baseC20H23NO4341.4116590-41-3 DihydrateC20H23NO4·HCl·2H2O413.89850808-02-5Chemical Info/CAS, IDENTIFICATION/A.Infrared Absorption <197K><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Total Solvents, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Completeness of Solution <641>, SPECIFIC TESTS/Clarity of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naltrexone Related Revision NALTREXONE HYDROCHLORIDE PF 43(6) Pg. ONLINE Compound A RS Hillary Cai

DEFINITION/Introduction, IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Revision NAPROXEN PF 42(4) Pg. ONLINE Reference Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L Revision NAPROXEN ORAL SUSPENSION PF 42(4) Pg. ONLINE RS Sujatha Ramakrishna

IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Delayed-Release Dosage Forms, Method B Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Revision NAPROXEN DELAYED-RELEASE TABLETS PF 42(4) Pg. ONLINE Standards <11>/USP Naproxen Related Compound L RS Richard Nguyen

IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision NAPROXEN SODIUM PF 42(4) Pg. ONLINE <11>/USP Naproxen Related Compound L RS Richard Nguyen

Title, Chemical Info/Chemical Structure, Chemical Info/C28H36O15, Chemical Info/ 612.58, Chemical Info/1-Propanone, 1-[4-[[2-O-(6-deoxy-α-l-mannopyranosyl)- β-d-glucopyranosyl]oxy]-2, 6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)- ;, Chemical Info/3,5-Dihydroxy-4-[3-(3-hydroxy-4-methoxyphenyl)propanoyl]phenyl 2- O-(α-l-rhamnopyranosyl)-β-d-glucopyranoside, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Neodiosmin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Neohesperidin New NEOHESPERIDIN DIHYDROCHALCONE PF 43(6) Pg. ONLINE Dihydrochalcone RS Peng Zhang Title, Chemical Info/Chemical Structure, Chemical Info/C20H24N2O6, Chemical Info/388.41, Chemical Info/3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4- (2-nitrophenyl)-, methyl 2-methylpropyl ester, (±)-;, Chemical Info/(±)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, 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 Nifedipine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision NISOLDIPINE PF 43(6) Pg. ONLINE <11>/USP Nisoldipine Related Compound G RS Donald Min

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethinyl Estradiol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS PF 43(6) Pg. ONLINE Norethindrone Related Compound B RS Ren-Hwa Yeh

IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature<741>, Class I, SPECIFIC TESTS/Limit of Ethynyl Group, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Revision NORGESTREL PF 43(6) Pg. ONLINE Standards <11>/USP Norgestrel Related Compound L RS Ren-Hwa Yeh

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxetine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxetine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision OLANZAPINE AND FLUOXETINE CAPSULES PF 42(5) Pg. ONLINE Olanzapine RS Gerald Hsu IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Orlistat Revision ORLISTAT CAPSULES PF 43(5) Pg. ONLINE Related Compound D RS Hillary Cai IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Revision OXAZEPAM CAPSULES PF 43(6) Pg. ONLINE IMPURITIES/Organic Impurities Gerald Hsu

IDENTIFICATION/A. Procedure, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Limit of Alcohol, IMPURITIES/Note, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2: Limit of Oxycodone Related Compound A (14-Hydroxycodeinone) and Oxycodone Related Compound C (Codeinone), IMPURITIES/3, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Codeine Phosphate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxycodone Related Compound C RS Also known as Codeinone; 4,5α-Epoxy-3-methoxy-17-methylmorphinan-7-ene-6- Revision OXYCODONE HYDROCHLORIDE PF 43(6) Pg. ONLINE one.C18H19NO3297.35 Hillary Cai IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/8-Bromotheophylline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision PAMABROM PF 43(2) Pg. ONLINE Standards <11>/USP Pamabrom Related Compound A RS Clydewyn Anthony

IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Revision PHENTOLAMINE MESYLATE PF 43(3) Pg. ONLINE Standards <11>/USP Phentolamine Amine Analog RS Donald Min IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound Revision PHENYLEPHRINE HYDROCHLORIDE INJECTION PF 43(5) Pg. ONLINE F RS Hillary Cai

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, ADDITIONAL Revision PHENYLEPHRINE HYDROCHLORIDE NASAL SOLUTION PF 44(1) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine Bitartrate RS Clydewyn Anthony

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, ADDITIONAL Revision PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION PF 44(1) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Epinephrine Bitartrate RS Clydewyn Anthony IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound Revision PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 43(5) Pg. ONLINE G RS Clydewyn Anthony

Title, Chemical Info/Chemical Structure, Chemical Info/C30H62O10, Chemical Info/ n = an average of nine (9), Chemical Info/582.8 (based on an average of 9 moieties), Chemical Info/Poly(oxy-1,2-ethanediyl), α-dodecyl-ω-hydroxy-;, Chemical Info/Polyethylene glycol monododecyl ether (average polymer, n = 9; nonaethylene glycol monododecyl ether), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, ASSAY/Distribution of Oligomers, ASSAY/Average Oligomer Chain Length, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ethylene Oxide and 1,4- Dioxane, IMPURITIES/Limit of Formaldehyde and Acetaldehyde, IMPURITIES/Limit of Formic Acid and Acetic Acid, SPECIFIC TESTS/Alkalinity, SPECIFIC TESTS/Appearance of Solution, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Hydroxyl Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Iodine Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Saponification Value, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference New POLIDOCANOL PF 43(5) Pg. ONLINE Standards <11>/USP Polidocanol RS Donald Min

Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pramipexole Dihydrochloride Monohydrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pramipexole Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pramipexole Related Compound New PRAMIPEXOLE DIHYDROCHLORIDE TABLETS PF 44(1) Pg. ONLINE G RS Ravi Ravichandran IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL Revision PRAZOSIN HYDROCHLORIDE CAPSULES PF 43(5) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Prazosin Hydrochloride RS Donald Min IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Revision PRIMIDONE TABLETS PF 44(1) Pg. ONLINE IMPURITIES/Organic Impurities Claire Chisolm

IDENTIFICATION/A. Infrared Absorption <197K> <197>, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone System Suitability Mixture RS, ADDITIONAL Revision PROGESTERONE PF 43(6) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/ Ren-Hwa Yeh

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone Revision PROGESTERONE INJECTION PF 43(6) Pg. ONLINE System Suitability Mixture RS Ren-Hwa Yeh

DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class Ia <741>, SPECIFIC TESTS/Optical Rotation <781S>, Specific Rotation, ADDITIONAL REQUIREMENTS/USP Reference Revision PROPRANOLOL HYDROCHLORIDE PF 43(6) Pg. ONLINE Standards <11>/ USP Propranolol Related Compound A RS Donald Min

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision PROPRANOLOL HYDROCHLORIDE INJECTION PF 44(1) Pg. ONLINE Propranolol Related Compound A RS Donald Min IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Propranolol Related Compound A Revision PROPRANOLOL HYDROCHLORIDE TABLETS PF 43(6) Pg. ONLINE RS Donald Min

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197M><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., IDENTIFICATION/D. X-Ray Diffraction <941>, ASSAY/Procedure, IMPURITIES/Organic Revision PROTRIPTYLINE HYDROCHLORIDE PF 43(4) Pg. ONLINE Impurities, SPECIFIC TESTS/pH <791> Claire Chisolm

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197A> or <197K>, IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/C., IDENTIFICATION/D., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Revision PYRIDOSTIGMINE BROMIDE PF 44(1) Pg. ONLINE Standards <11>/USP Pyridostigmine Related Compound B RS Claire Chisolm Title, Chemical Info/Chemical Structure, Chemical Info/C17H26N2O, Chemical Info/274.40, Chemical Info/(S)-(-)-1-Propylpiperidine-2-carboxylic acid (2,6- dimethylphenyl)-amide;, Chemical Info/(S)-(-)-1-Propyl-2′,6′- pipecoloxylidide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ropivacaine Related Compound A, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Color, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupivacaine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference New ROPIVACAINE PF 43(1) Pg. ONLINE Standards <11>/USP Ropivacaine Related Compound B RS Ren-Hwa Yeh

Title, Chemical Info/Chemical Structure, Chemical Info/C19H25NOS, Chemical Info/315.47, Chemical Info/1-Naphthalenol, 5,6,7,8-tetrahydro-6-[propyl [2-(2- thienyl)ethyl]amino-(6S)-;, Chemical Info/(-)-(S)-5,6,7,8-Tetrahydro-6-[propyl[2-(2- thienyl)ethyl]amino]-1-naphthol;, Chemical Info/(6S)-6-[Propyl(2-(2- thienyl)ethyl)amino]-5,6,7,8-tetrahydro-1-naphthalenol, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Rotigotine R-Enantiomer, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine New ROTIGOTINE PF 43(5) Pg. ONLINE Racemate RS Ravi Ravichandran

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Drug Release <724>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rotigotine Related Compound K New ROTIGOTINE TRANSDERMAL SYSTEM PF 43(5) Pg. ONLINE RS Ravi Ravichandran IDENTIFICATION/A. Procedure, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Revision SALICYLIC ACID GEL PF 44(1) Pg. ONLINE Reference Standards <11> Clydewyn Anthony IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Revision SALICYLIC ACID PLASTER PF 43(2) Pg. ONLINE Related Compound B RS Clydewyn Anthony IDENTIFICATION/A., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Revision SELENIUM SULFIDE TOPICAL SUSPENSION PF 43(3) Pg. ONLINE Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Revision SERTRALINE HYDROCHLORIDE TABLETS PF 44(1) Pg. ONLINE Impurities Claire Chisolm

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, 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/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination <921>, Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ligusticum chuanxiong Rhizome Powder RS, ADDITIONAL New SICHUAN LOVAGE RHIZOME PF 43(4) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Z-Ligustilide RS Cuiying Ma

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, 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/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid- Insoluble Ash, SPECIFIC TESTS/Water Determination <921>, Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ligusticum chuanxiong Rhizome Powder RS, ADDITIONAL REQUIREMENTS/USP Reference New SICHUAN LOVAGE RHIZOME POWDER PF 43(4) Pg. ONLINE Standards <11>/USP Z-Ligustilide RS Cuiying Ma IMPURITIES/Limit of Sodium Sarcosinate, IMPURITIES/Limit of Sodium Laurate, IMPURITIES/Limit of Sodium Sulfate, 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 Chloride, 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 Revision SODIUM LAUROYL SARCOSINATE PF 43(4) Pg. ONLINE Sodium Myristoyl Sarcosinate RS Hong Wang

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Fluoride Ion, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Monofluorophosphate RS, ADDITIONAL Revision SODIUM MONOFLUOROPHOSPHATE PF 43(4) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Sodium Sulfate RS Michael Chang

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 Revision SODIUM THIOSULFATE INJECTION PF 43(2) Pg. ONLINE Sodium Thiosulfate RS Donald Min

IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Epimer Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Revision SPIRONOLACTONE PF 42(1) Pg. ONLINE Related Compound I RS Donald Min DEFINITION/Introduction, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Selenium <291>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class I <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfamethoxazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfamethoxazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfamethoxazole Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfamethoxazole Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfanilamide RS, Revision SULFAMETHOXAZOLE PF 43(6) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfanilic Acid RS Praveen Pabba

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 New TACROLIMUS OINTMENT PF 43(3) Pg. ONLINE Compound A RS Praveen Pabba

IDENTIFICATION/A. Infrared Absorption <197K>or <197A>, IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Sulfate, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terbutaline Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terbutaline Related Compound D Revision TERBUTALINE SULFATE PF 44(1) Pg. ONLINE RS Ren-Hwa Yeh IDENTIFICATION/A. Thin Layer Chromatography, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terbutaline Related Compound A Revision TERBUTALINE SULFATE INJECTION PF 44(1) Pg. ONLINE RS Ren-Hwa Yeh

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Immediate- Release Dosage Forms, Procedure for a pooled sample, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terbutaline Related Revision TERBUTALINE SULFATE TABLETS PF 44(1) Pg. ONLINE Compound A RS Ren-Hwa Yeh

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 Revision TESTOSTERONE ENANTHATE PF 43(3) Pg. ONLINE Testosterone Enanthate Related Compound H RS Ren-Hwa Yeh 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 Revision TESTOSTERONE ENANTHATE INJECTION PF 43(3) Pg. ONLINE Compound G RS Ren-Hwa Yeh

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

Title, DEFINITION/Introduction, IDENTIFICATION/A. 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 Tranexamic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tranexamic Acid New TRANEXAMIC ACID TABLETS PF 43(6) Pg. ONLINE Related Compound C RS Donald Min

DEFINITION/Introduction, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxymesterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Revision TRIAMCINOLONE ACETONIDE PF 43(5) Pg. ONLINE Acetonide Related Compound C RS Ren-Hwa Yeh

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, Revision TRIAMCINOLONE ACETONIDE OINTMENT PF 43(5) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norethindrone RS Ren-Hwa Yeh

DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms Revision TRIHEXYPHENIDYL HYDROCHLORIDE ORAL SOLUTION PF 42(5) Pg. ONLINE <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Sridevi Ramachandran Title, Chemical Info/Chemical Structure, Chemical Info/C64H82N18O13 · C23H16O6, Chemical Info/1311.45 (free base), Chemical Info/6-d-Tryptophan-, 4,4′- 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 New TRIPTORELIN PAMOATE PF 43(3) Pg. ONLINE Related Compound C RS Dale Schmidt

{Title}, Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities: Limit of Chymotrypsin, SPECIFIC TESTS/Solubility Test, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trypsin Crystallized RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trypsin Bovine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trypsin Revision TRYPSIN PF 43(6) Pg. ONLINE Recombinant Porcine RS Diane McCarthy New UNDECANOIC ACID PF 42(4) Pg. ONLINE Undecanoic Acid Hong Wang Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F> or <197A>, IDENTIFICATION/B. 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 Revision MICROCRYSTALLINE WAX PF 43(2) Pg. ONLINE <11> Hong Wang

Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F> or <197A>, IDENTIFICATION/B. Ultraviolet Absorption, SPECIFIC TESTS/Saponification Cloud Test, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class II, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Ester Value, ADDITIONAL Revision WHITE WAX PF 42(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Hong Wang

Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F> or <197A>, IDENTIFICATION/B. Ultraviolet Absorption, SPECIFIC TESTS/Saponification Cloud Test, SPECIFIC TESTS/Melting Range or Temperature <741>, Procedures, Class II, SPECIFIC TESTS/Fats and Fixed Oils <401>, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Ester Value, ADDITIONAL Revision YELLOW WAX PF 42(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Hong Wang DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Particulate Matter in Injections <788>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP New ZINC SULFATE COMPOUNDED INJECTION PF 41(2) Pg. ONLINE Reference Standards <11>/USP Zinc Sulfate RS Jeanne Sun