Compendial Deferrals for USP42-NF37 1S

Category Monograph Title Monograph Section Scientific Liaison

{Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent}, {Flavors and Fragrance} Neohesperidin Dihydrochalcone NF, {Sweetening Agent} Neohesperidin Dihydrochalcone NF, {Flavors Revision EXCIPIENTS (USP and NF), LISTED BY CATEGORY PF 42(2) Pg. ONLINE and Fragrance} Anise Oil, {Flavors and Fragrance} Star Anise Oil 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, Gadobutrol, Rotigotine, Deferasirox, Eletriptan Hydrobromide, Milnacipran Hydrochloride, Neohesperidin Dihydrochalcone, Tetrabenazine, Anise Oil, Choline Fenofibrate, Revision DESCRIPTION AND SOLUBILITY PF 43(4) Pg. ONLINE Nisoldipine, Star Anise Oil 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/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 DEFINITIONS, SYSTEM SUITABILITY, ADJUSTMENT OF CHROMATOGRAPHIC New <621> CHROMATOGRAPHY PF 43(5) Pg. ONLINE CONDITIONS, QUANTIFICATION Horacio Pappa Introduction, INTRODUCTION, MOISTURE VAPOR TRANSMISSION FOR PLASTIC PACKAGING SYSTEMS, CLASSIFICATION SYSTEM FOR PLASTIC PACKAGING SYSTEMS, Revision <671> CONTAINERS--PERFORMANCE TESTING PF 44(3) Pg. ONLINE SPECTRAL TRANSMISSION Desmond Hunt Revision <701> DISINTEGRATION PF 44(2) Pg. ONLINE APPARATUS William Brown

Introduction, INTRODUCTION, CATEGORIES OF COMPOUNDING, RESPONSIBILITIES OF THE COMPOUNDER, COMPOUNDING PROCESS, COMPOUNDING FACILITIES, COMPOUNDING EQUIPMENT, COMPONENT SELECTION, HANDLING, AND STORAGE, STABILITY CRITERIA AND BEYOND-USE DATING, PACKAGING AND DRUG PREPARATION CONTAINERS, COMPOUNDING DOCUMENTATION, QUALITY CONTROL, PATIENT COUNSELING, TRAINING, COMPOUNDING FOR ANIMAL PATIENTS, GLOSSARY, 1. INTRODUCTION AND SCOPE, 2. PERSONNEL QUALIFICATIONS- TRAINING, EVALUATION, AND REQUALIFICATION, 3. PERSONAL HYGIENE AND GARBING, 4. BUILDINGS AND FACILITIES, 5. CLEANING AND SANITIZING, 6. EQUIPMENT AND COMPONENTS, 7. SOPS AND MASTER FORMULATION AND COMPOUNDING RECORDS, 8. RELEASE TESTING, 9. LABELING, 10. ESTABLISHING BEYOND-USE DATES, 11. QUALITY ASSURANCE AND QUALITY CONTROL, 12. CNSP <795> PHARMACEUTICAL COMPOUNDING--NONSTERILE PREPARATIONS PF 44(3) Pg. HANDLING, PACKAGING, STORAGE, AND TRANSPORT, 13. COMPLAINT HANDLING Revision ONLINE AND ADVERSE EVENT REPORTING, 14. DOCUMENTATION, APPENDIX Jeanne Sun <915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY New PENETROMETRY PF 43(2) Pg. ONLINE Title, INTRODUCTION, PROCEDURE, GLOSSARY Antonio Hernandez-Cardoso

Revision <1226> VERIFICATION OF COMPENDIAL PROCEDURES PF 44(3) Pg. ONLINE VERIFICATION REQUIREMENTS Horacio Pappa

Introduction, INTRODUCTION, PACKAGING SYSTEMS, DESICCANT VERSUS WATER <1671> THE DETERMINATION AND APPLICATION OF MOISTURE VAPOR MVTR METHOD, EQUIVALENCY AND APPLICATION OF MVTR DETERMINATION New TRANSMISSION RATE PF 44(3) Pg. ONLINE METHOD, REPACKAGING OF SODFS, GLOSSARY, REFERENCES Desmond Hunt Title, Introduction, 1. INTRODUCTION, 2. APPLICATION OF THE TECHNOLOGY, 3. <1850> EVALUATION OF SCREENING TECHNOLOGIES FOR ASSESSING MEDICINE GENERAL INFORMATION ABOUT THE TECHNOLOGY, 4. PERFORMANCE EVALUATION, New QUALITY PF 44(3) Pg. ONLINE 5. FIELD EVALUATION, GLOSSARY, REFERENCES Daniel Bempong

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

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 DEFINITION/Introduction, ASSAY/Oral Suspension in SyrSpend SF PH4, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/USP Reference Revision ALLOPURINOL COMPOUNDED ORAL SUSPENSION PF 44(2) Pg. ONLINE Standards <11> Brian Serumaga

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

IDENTIFICATION/Thin-Layer Chromatography, ASSAY/Procedure, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL Revision AMCINONIDE CREAM PF 44(3) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Butylparaben RS Mary Koleck

IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Benzyl Alcohol (if present), IMPURITIES/Limit of Iodide, IMPURITIES/Organic Impurities, Revision AMIODARONE HYDROCHLORIDE INJECTION PF 44(3) Pg. ONLINE SPECIFIC TESTS/Bacterial Endotoxins Test <85> Edith Chang

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amlodipine Besylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amlodipine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS PF 44(2) Pg. ONLINE Olmesartan Medoxomil RS Edith Chang 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

DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, IDENTIFICATION/B. Refractive Index, ASSAY/Content of trans-Anethole, IMPURITIES/Limit of Phenols, SPECIFIC TESTS/Specific Gravity <841>, SPECIFIC TESTS/Congealing Temperature <651>, SPECIFIC TESTS/Optical Rotation, Angular Rotation <781A>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL Revision ANISE OIL PF 44(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Galina Holloway

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

IDENTIFICATION/B. Infrared Absorption <197A>, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision AZITHROMYCIN TABLETS PF 44(3) Pg. ONLINE Standards <11>/USP N-Demethylazithromycin RS Praveen Pabba Omission BELLADONNA LEAF PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim Omission BELLADONNA EXTRACT PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim Omission BELLADONNA EXTRACT TABLETS PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim Omission BELLADONNA TINCTURE PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim

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

Chemical Info/403.53403.54, (1R,3r,5S)-3-(Benzhydryloxy)-8-methyl-8- azabicyclo[3.2.1]octane methanesulfonate, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Loss on Drying <731>, 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 Benztropine Related Compound Revision BENZTROPINE MESYLATE PF 44(3) Pg. ONLINE A RS Heather Joyce

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, 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 Benztropine Related Compound Revision BENZTROPINE MESYLATE INJECTION PF 44(3) Pg. ONLINE A RS Heather Joyce IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Revision BENZTROPINE MESYLATE TABLETS PF 44(3) Pg. ONLINE Standards <11>/USP Benztropine Related Compound A RS Heather Joyce

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 Title, Chemical Info/Chemical Structure, Chemical Info/C98H138N24O33, Chemical Info/2180.29 (free base), Chemical Info/l-Leucine, d-phenylalanyl-l-prolyl-l-arginyl-l- prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-α-aspartyl-l-phenylalanyl-l- α-glutamyl-l-α-glutamyl-l-isoleucyl-l-prolyl-l-α-glutamyl-l-α- glutamyl-l-tyrosyl-;, Chemical Info/d-Phenylalanyl-l-prolyl-l-arginyl-l- prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-α-aspartyl-l-phenylalanyl-l- α-glutamyl-l-α-glutamyl-l-isoleucyl-l-prolyl-l-α-glutamyl-l-α- glutamyl-l-tyrosyl-l-leucine, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C. Amino Acid Content, IDENTIFICATION/D. Bioidentity, ASSAY/Procedure, ??UNKNOWN??/Procedure 1, ??UNKNOWN??/Procedure 2, OTHER COMPONENTS/Trifluoroacetic Acid (TFA) in Peptides <503.1>, SPECIFIC TESTS/Microbial Enumeration Tests <61>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [Asp9]-Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP New BIVALIRUDIN PF 44(2) Pg. ONLINE Reference Standards <11>/USP [des-Glu13]-Bivalirudin RS Elena Curti

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Bioidentity, ASSAY/Procedure, ??UNKNOWN??/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, SPECIFIC TESTS/Completeness of Solution <641>, SPECIFIC TESTS/Constituted Solution, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [Asp9]-Bivalirudin New BIVALIRUDIN FOR INJECTION PF 44(2) Pg. ONLINE RS Elena Curti

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, OTHER COMPONENTS/Content of Potassium Sorbate, OTHER COMPONENTS/Content of Edetate Disodium, PERFORMANCE TESTS/Delivered-Dose Uniformity, PERFORMANCE TESTS/Minimum Fill <755>, 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 Budesonide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Edetate Disodium RS, ADDITIONAL REQUIREMENTS/USP New BUDESONIDE NASAL SPRAY PF 44(3) Pg. ONLINE Reference Standards <11>/USP Potassium Sorbate RS Richard Nguyen

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 Revision LOW-SUBSTITUTED CARBOXYMETHYLCELLULOSE SODIUM PF 43(6) Pg. ONLINE Reference Standards <11> Tong Liu

IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Procedure 2, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Water Determination <921>, Method I, Revision CEFEPIME FOR INJECTION PF 44(2) Pg. ONLINE ADDITIONAL REQUIREMENTS/Packaging and Storage Slavica Shane

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, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision CEFOTETAN FOR INJECTION PF 43(6) Pg. ONLINE <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 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

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavone Glucuronides and Flavone Aglycons, 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/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein 7-O- Glucuronide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New CHINESE SKULLCAP ROOT PF 44(2) Pg. ONLINE Scutellaria baicalensis Root Dry Extract RS Cuiying Ma Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavone Glucuronides and Flavone Aglycons, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, 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/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baicalein 7-O-Glucuronide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Scutellaria baicalensis Root Dry New CHINESE SKULLCAP ROOT DRY EXTRACT PF 44(2) Pg. ONLINE Extract RS Cuiying Ma

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 Revision CHLORZOXAZONE TABLETS PF 43(4) Pg. ONLINE Standards <11>/USP 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, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, 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/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Apigenin-7- glucoside RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Luteolin 7-O- New CHRYSANTHEMUM FLOWER PF 44(2) Pg. ONLINE Glucoside RS Cuiying Ma Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, 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/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Apigenin-7-glucoside RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP New CHRYSANTHEMUM FLOWER DRY EXTRACT PF 44(2) Pg. ONLINE Reference Standards <11>/USP Luteolin 7-O-Glucoside RS Cuiying Ma

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 ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Revision CLINDAMYCIN INJECTION PF 44(2) Pg. ONLINE Reference Standards <11>/USP Clindamycin Phosphate System Suitability RS Ramanujam Prasad IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL Revision CLINDAMYCIN HYDROCHLORIDE CAPSULES PF 44(2) Pg. ONLINE REQUIREMENTS/Packaging and Storage Ramanujam Prasad

ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests Revision CLINDAMYCIN PHOSPHATE PF 44(3) Pg. ONLINE <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85> Ramanujam Prasad

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Revision CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION PF 44(2) Pg. ONLINE Reference Standards <11>/USP Clindamycin Phosphate System Suitability RS Ramanujam Prasad

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Revision CLINDAMYCIN PHOSPHATE VAGINAL INSERTS PF 44(2) Pg. ONLINE Reference Standards <11>/USP Clindamycin Phosphate System Suitability RS Ramanujam Prasad

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

IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Clonazepam Related Compound C, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision CLONAZEPAM PF 44(3) Pg. ONLINE Clonazepam Related Compound C RS Heather Joyce IDENTIFICATION/Infrared Absorption, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL Revision CLONAZEPAM TABLETS PF 44(3) Pg. ONLINE REQUIREMENTS/Packaging and Storage Heather Joyce

Title, Chemical Info/Chemical Structure, Chemical Info/C4H9N3O2·H2O, Chemical Info/149.15, Chemical Info/Glycine, N-(aminoiminomethyl)-N-methyl-, monohydrate;, Chemical Info/N-Carbamimidoyl-N-methylglycine monohydrate, Chemical Info/CAS, Chemical Info/C4H9N3O2, Chemical Info/131.14, Chemical Info/Anhydrous, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Chloride and Sulfate <221>, Sulfate, ??UNKNOWN??/Note, ??UNKNOWN??/Procedure 1, ??UNKNOWN??/Procedure 2, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Creatine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New CREATINE PF 44(3) Pg. ONLINE <11>/USP Creatinine RS Huy Dinh Revision CYPROHEPTADINE HYDROCHLORIDE TABLETS PF 43(1) Pg. ONLINE IMPURITIES/Organic Impurities Mary Koleck

Chemical Info/1H-Imidazole-4-carboxamide, 5-(3,3-dimethyl-1-triazenyl)-;1H- Imidazole-4-carboxamide, 5-(3,3-dimethyltriaz-1-enyl)-;, Chemical Info/5-(3,3- Dimethyl-1-triazeno)imidazole-4-carboxamide5-(3,3-Dimethyltriaz-1-enyl)-1H- imidazole-4-carboxamide, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Dimethylamine, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ 5-Aminoimidazole-4-carboxamide hydrochloride.C4H6N4O·HCl 162.58, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision DACARBAZINE PF 44(2) Pg. ONLINE Dimethylamine Solution RS Feiwen Mao IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Limit of 2-Azahypoxanthine, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Particulate Matter in Injections <788>, ADDITIONAL REQUIREMENTS/USP Revision DACARBAZINE FOR INJECTION PF 44(2) Pg. ONLINE Reference Standards <11>/ Feiwen Mao

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 New DEFERASIROX PF 43(3) Pg. ONLINE Standards <11>/USP Deferasirox System Suitability Mixture RS Andrea Carney

IDENTIFICATION/A. Infrared Absorption <197K>or <197A>, IDENTIFICATION/B. Thin- Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision DESOXIMETASONE PF 44(2) Pg. ONLINE Desoximetasone Related Compound A RS Mary Koleck

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/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, Revision DEXAMETHASONE ORAL SOLUTION PF 43(6) Pg. ONLINE ADDITIONAL 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, 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>, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diclofenac Potassium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New DICLOFENAC POTASSIUM FOR ORAL SOLUTION PF 44(3) Pg. ONLINE Diclofenac Related Compound A RS Wei Yang

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Benzyl Alcohol (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 Standards <11>/USP Benzyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diclofenac Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Diclofenac Related New DICLOFENAC SODIUM TOPICAL GEL PF 44(3) Pg. ONLINE Compound A 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 Revision DICYCLOMINE HYDROCHLORIDE PF 43(6) Pg. ONLINE 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 Revision DICYCLOMINE HYDROCHLORIDE INJECTION PF 43(6) Pg. ONLINE A 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 Standards <11>/USP Dicyclomine Related Compound Revision DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION PF 43(6) Pg. ONLINE 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 Omission DIGITALIS PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim Omission POWDERED DIGITALIS PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim Omission DIGITALIS CAPSULES PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim Omission DIGITALIS TABLETS PF 44(3) Pg. ONLINE Entire document Nam-Cheol Kim 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 New DONG QUAI ROOT PF 43(5) Pg. ONLINE REQUIREMENTS/USP 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

Chemical Info/ (4S,4aR,5S,5aR,6R,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a- octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2- naphthacenecarboxamide monohydrate, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxycycline Monohydrate RS, ADDITIONAL REQUIREMENTS/USP Revision DOXYCYCLINE PF 44(2) Pg. ONLINE Reference Standards <11>/USP Doxycycline Related Compound A RS Praveen Pabba Chemical Info/Chemical Structure, Chemical Info/ (4S,4aR,5S,5aR,6R,12aS)-4- (Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6- methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/USP Reference Revision DOXYCYCLINE HYCLATE PF 44(2) Pg. ONLINE Standards <11>/USP Doxycycline Related Compound A RS Praveen Pabba

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

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/C20H31NaO5, Chemical Info/374.45, Chemical Info/Prosta-5,13-dien-1-oic acid, 6,9-epoxy-11,15-dihydroxy-, sodium salt, (5Z,9α,11α,13E,15S)-;, Chemical Info/Sodium (Z)- (3aR,4R,5R,6aS)-hexahydro-5-hydroxy-4-[(E)-(3S)-3-hydroxy-1-octenyl]-2H- cyclopenta[b]furan-Δ2-valerate;, Chemical Info/Sodium (Z)-5-{(3aR,4R,5R,6aS)- 5-hydroxy-4-[(S,E)-3-hydroxyoct-1-en-1-yl]hexahydro-2H-cyclopenta[b]furan-2- ylidene}pentanoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Sodium, ASSAY/Procedure, IMPURITIES/Limit of Sodium Hydroxide, IMPURITIES/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 Epoprostenol Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epoprostenol New EPOPROSTENOL SODIUM PF 44(2) Pg. ONLINE Sodium System Suitability Mixture RS Gerald Hsu Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Constituted Solution, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epoprostenol Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epoprostenol New EPOPROSTENOL FOR INJECTION PF 44(2) Pg. ONLINE Related Compound A RS Gerald Hsu

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, New EPTACOG ALFA ACTIVATED PF 41(3) Pg. ONLINE IMPURITIES/Gla-Domainless Eptacog Alfa Activated (γ-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 Omission ERGOLOID MESYLATES SUBLINGUAL TABLETS PF 44(2) Pg. ONLINE Entire document Heather Joyce Omission ERGOTAMINE TARTRATE SUBLINGUAL TABLETS PF 44(2) Pg. ONLINE Entire document Heather Joyce IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Citalopram Related Compound B, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Citalopram Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Citalopram Related Compound C Revision ESCITALOPRAM ORAL SOLUTION PF 44(2) Pg. ONLINE RS Heather Joyce 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 <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 IDENTIFICATION/ A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluconazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluconazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluconazole Related Compound Revision FLUCONAZOLE TABLETS PF 44(3) Pg. ONLINE C RS Shankari Shivaprasad Revision FLUOXETINE HYDROCHLORIDE PF 43(6) Pg. ONLINE IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities Heather Joyce Revision FOSFOMYCIN TROMETHAMINE PF 44(2) Pg. ONLINE IMPURITIES/Organic Impurities Shankari Shivaprasad

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

Title, Chemical Info/Chemical Structure, Chemical Info/C16H25GdN4O8·C7H17NO5, Chemical Info/753.86, Chemical Info/d-Glucitol, 1-deoxy-1-(methylamino)-, [1,4,7,10- tetraazacyclododecane-1,4,7,10-tetraacetato(4-)- &kgr;N1,&kgr;N4,&kgr;N7,&kgr;N10,&kgr;O1,&kgr;O4,&kgr;O7,&kgr;O10]gadolinate( 1-) (1:1);, Chemical Info/1-Deoxy-1-(methylamino)-d-glucitol hydrogen [1,4,7,10- tetraazacyclododecane-1,4,7,10-tetraacetato(4-)- &kgr;N1,&kgr;N4,&kgr;N7,&kgr;N10,&kgr;O1,&kgr;O4,&kgr;O7,&kgr;O10]gadolinate( 1-), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Meglumine, IMPURITIES/Limit of Free Gadolinium, IMPURITIES/Limit of Free Tetraxetan, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Container Content for Injections <697>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gadoterate New GADOTERATE MEGLUMINE INJECTION PF 44(3) Pg. ONLINE Meglumine RS Ravi Ravichandran ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Galantamine Hydrobromide Related Compounds Revision GALANTAMINE ORAL SOLUTION PF 44(3) Pg. ONLINE Mixture RS Heather Joyce

DEFINITION/Introduction, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Galantamine Revision GALANTAMINE EXTENDED-RELEASE CAPSULES PF 44(3) Pg. ONLINE Hydrobromide Related Compounds Mixture RS Heather Joyce

IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision GALANTAMINE TABLETS PF 44(3) Pg. ONLINE <11>/USP Galantamine Hydrobromide Related Compounds Mixture RS Heather Joyce

Chemical Info/Chemical Name (4aS,6R,8aS)-3-Methoxy-11-methyl-4a,5,9,10,11,12- hexahydro-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide; (4aS,6R,8aS)-3- Methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3- cd]azepin-6-ol hydrobromide, IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Bromide, ASSAY/Procedure, IMPURITIES/Limit of Palladium, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation <781><781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Galantamine Hydrobromide Racemic RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Galantamine Hydrobromide Related Compounds Revision GALANTAMINE HYDROBROMIDE PF 44(3) Pg. ONLINE Mixture RS Heather Joyce

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 DEFINITION/Introduction, IDENTIFICATION/B., SPECIFIC TESTS/Bacterial Endotoxins Revision GLUCAGON PF 44(3) Pg. ONLINE Test <85>, ADDITIONAL REQUIREMENTS/Labeling Elena Curti

Chemical Info/1374.461182.3 (acetic acid free, anhydrous), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Acetic Acid in Peptides <503>, ??UNKNOWN??/Gonadorelin-Related Impurities, Procedure 1, ??UNKNOWN??/Gonadorelin-Related Impurities, Procedure 2, ??UNKNOWN??/Acetic Acid and Trifluoroacetic Acid, ??UNKNOWN??/Limit of Fluoride, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Amino Acid Analysis, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [D-His2]-Gonadorelin RS, ADDITIONAL REQUIREMENTS/USP Reference Revision GONADORELIN ACETATE PF 44(2) Pg. ONLINE Standards <11>/USP [D-Tyr5]-Gonadorelin RS Michael Huang 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

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeine and Flavonoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, 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 Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (+)-Catechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (−)-Epicatechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guarana Seed Dry Extract RS, ADDITIONAL New GUARANA SEED PF 44(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Procyanidin B2 RS Maria Monagas

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC for Flavonoids, COMPOSITION/Content of Caffeine, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (+)-Catechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (−)-Epicatechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guarana Seed Dry Extract RS, ADDITIONAL New GUARANA SEED DRY EXTRACT PF 44(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Procyanidin B2 RS Maria Monagas Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeine and Flavonoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, 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 Caffeine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (+)-Catechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP (−)-Epicatechin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guarana Seed Dry Extract RS, ADDITIONAL New GUARANA SEED POWDER PF 44(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Procyanidin B2 RS Maria Monagas

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

IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cortisone Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydrocortisone RS, ADDITIONAL REQUIREMENTS/USP Revision HYDROCORTISONE ACETATE PF 44(3) Pg. ONLINE Reference Standards <11>/USP Prednisolone Acetate RS Gerald Hsu

IDENTIFICATION/Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure, 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 Cortisone Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydrocortisone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prednisolone Revision HYDROCORTISONE ACETATE CREAM PF 44(3) Pg. ONLINE Acetate RS Gerald Hsu IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/B. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/Ordinary Impurities Revision HYDROXYCHLOROQUINE SULFATE PF 44(2) Pg. ONLINE <466>, IMPURITIES/Organic Impurities Shankari Shivaprasad Revision HYDROXYCHLOROQUINE SULFATE TABLETS PF 44(3) Pg. ONLINE ASSAY/Procedure, PERFORMANCE TESTS/Organic Impurities Shankari Shivaprasad

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

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, 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 New L-ALPHA-GLYCERYLPHOSPHORYLCHOLINE PF 43(5) Pg. ONLINE RS, ADDITIONAL 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 New LACOSAMIDE PF 43(6) Pg. ONLINE <11>/USP 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, 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 New LACTULOSE PF 43(3) Pg. ONLINE Reference Standards <11>/USP Lactulose RS Andrea Carney 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

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., COMPOSITION/Content of Conjugated Linoleic Acids-Tri-, Di-, Monoglycerides and Polymerized Triglycerides, IMPURITIES/Limit of Benzo[a]pyrene, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Peroxide Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Fatty Acid Composition, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Conjugated Linoleic New CONJUGATED LINOLEIC ACIDS-TRIGLYCERIDES PF 44(2) Pg. ONLINE Acids-Triglycerides RS Huy Dinh

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/B., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/USP Reference Revision MILK OF MAGNESIA PF 44(3) Pg. ONLINE Standards <11> Michael Chang

IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Carbonate, ASSAY/Procedure, IMPURITIES/Limit of Calcium, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL Revision MAGNESIUM CARBONATE PF 44(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Michael Chang

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, IMPURITIES/Limit of Lead, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision MAGNESIUM HYDROXIDE PASTE PF 44(3) Pg. ONLINE <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 IDENTIFICATION/B., ASSAY/Content of Magnesium Oxide, IMPURITIES/Soluble Salts, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL Revision MAGNESIUM TRISILICATE PF 44(2) Pg. ONLINE REQUIREMENTS/USP Reference Standards <11> Michael Chang Omission MANGANESE CHLORIDE FOR ORAL SOLUTION PF 44(2) Pg. ONLINE Entire document 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 Omission METAPROTERENOL SULFATE INHALATION SOLUTION PF 44(2) Pg. ONLINE Entire document Ravi Ravichandran 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 Omission METHYLCELLULOSE OPHTHALMIC SOLUTION PF 44(3) Pg. ONLINE Entire document Feiwen Mao Omission METHYLCELLULOSE ORAL SOLUTION PF 44(3) Pg. ONLINE Entire document Feiwen Mao

IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Revision METHYLPREDNISOLONE PF 44(3) Pg. ONLINE Related Compound H RS Gerald Hsu

IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylprednisolone Hemisuccinate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Revision METHYLPREDNISOLONE HEMISUCCINATE PF 44(3) Pg. ONLINE Standards <11>/USP Methylprednisolone Hemisuccinate Related Compound D RS Gerald Hsu Omission METHYSERGIDE MALEATE PF 44(3) Pg. ONLINE Entire document Mary Koleck 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 Omission MINOCYCLINE HYDROCHLORIDE ORAL SUSPENSION PF 44(3) Pg. ONLINE Entire document Praveen Pabba IDENTIFICATION/A. Infrared Absorption <197M><197>, IDENTIFICATION/B., Revision MINOXIDIL PF 44(2) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Donald Min

IDENTIFICATION/Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, Revision MINOXIDIL TABLETS PF 44(2) Pg. ONLINE ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nabumetone Related Compound Revision NABUMETONE TABLETS PF 44(3) Pg. ONLINE 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. 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/C28H22F3N7O·HCl·H2O, Chemical Info/584.00, Chemical Info/Benzamide, 4-methyl-N-[3-(4-methyl-1H- imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino, monohydrochloride, monohydrate;, Chemical Info/4-Methyl-N-[3-(4-methyl-1H- imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-{[4-(pyridin-3-yl)pyrimidin-2- yl]amino}benzamide hydrochloride monohydrate, Chemical Info/CAS, Chemical Info/C28H22F3N7O, Chemical Info/529.52, Chemical Info/Free base, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197M>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Nilotinib Related Compound A, Nilotinib Related Compound B, and Nilotinib Related Compound C, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New NILOTINIB PF 44(3) Pg. ONLINE <11>/USP Nilotinib System Suitability Mixture RS Feiwen Mao 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, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,2-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,3- Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1-Mononitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision DILUTED NITROGLYCERIN PF 44(3) Pg. ONLINE <11>/USP 2-Mononitroglycerin RS Donald Min

IDENTIFICATION/A., 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 1,2-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,3-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1-Mononitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 2- Revision NITROGLYCERIN INJECTION PF 44(3) Pg. ONLINE Mononitroglycerin RS Donald Min

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,2-Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1,3- Dinitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 1-Mononitroglycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards Revision NITROGLYCERIN SUBLINGUAL TABLETS PF 44(3) Pg. ONLINE <11>/USP 2-Mononitroglycerin RS Donald Min Omission NITROMERSOL PF 44(3) Pg. ONLINE Entire document Shankari Shivaprasad

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/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, Procedure 1: Norethindrone Acetate Related Compounds, IMPURITIES/Organic Impurities, Procedure 2: Ethinyl Estradiol Related Compounds, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS PF 44(3) Pg. ONLINE Estrone 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 Omission NORGESTREL TABLETS PF 44(3) Pg. ONLINE Entire document Ren-Hwa Yeh

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., COMPOSITION/Content of EPA, DHA, and Total Omega-3 Free Fatty Acids, IMPURITIES/Cholesterol, IMPURITIES/Oligomers, IMPURITIES/Limit of Dioxins, Furans, and Polychlorinated Biphenyls (PCBs), IMPURITIES/Limit of Total Unidentified Fatty Acid Methyl Esters, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Acid Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Anisidine Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Peroxide Value, SPECIFIC TESTS/Fats and Fixed Oils <401>, Procedures, Ester Value, SPECIFIC TESTS/Absorbance, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cholesterol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Docosahexaenoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Eicosapentaenoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Tricosanoate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omega-3 Free Fatty Acids RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New OMEGA-3 FREE FATTY ACIDS PF 44(3) Pg. ONLINE Alpha Tocopherol RS Huy Dinh

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Sodium, IDENTIFICATION/D. Identification Tests-General <191>, Chemical Identification Tests, Bicarbonate, ASSAY/Procedure for Omeprazole, ASSAY/Procedure for Sodium Bicarbonate, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Acid-Neutralizing Capacity <301>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound F and G Mixture RS, OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION PF 44(3) Pg. ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole New ONLINE Related Compound I RS Richard Nguyen 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 Revision OXAPROZIN PF 44(2) Pg. ONLINE IDENTIFICATION/, IMPURITIES/Organic Impurities 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. 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 IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Revision PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 43(5) Pg. ONLINE Compound G RS Clydewyn Anthony New 0.2% PHOSPHORIC ACID TS PF 44(3) Pg. ONLINE 0.2% Phosphoric Acid TS- Sridevi Ramachandran

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 Standards <11>/USP New POLIDOCANOL PF 43(5) Pg. ONLINE Polidocanol RS Donald Min

2,4-Hexadienoic acid, potassium salt;, Chemical Info/Chemical Name Potassium (2E,4E)-hexa-2,4-dienoate;, Chemical Info/Chemical Name, DEFINITION/Introduction, IDENTIFICATION/B.Infrared Absorption <197A> or <197K>, ASSAY/Procedure, ASSAY/Procedure 1: Content of Potassium Sorbate, ASSAY/Procedure 2: Content of Potassium, IMPURITIES/Limit of Aldehyde, ADDITIONAL REQUIREMENTS/USP Revision POTASSIUM SORBATE PF 44(2) Pg. ONLINE Reference Standards <11> Peng Zhang 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 REQUIREMENTS/USP Reference Standards Revision PROGESTERONE PF 43(6) Pg. ONLINE <11>/ 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 Revision PROPRANOLOL HYDROCHLORIDE PF 43(6) Pg. ONLINE Reference 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 Revision PROPRANOLOL HYDROCHLORIDE TABLETS PF 43(6) Pg. ONLINE A RS Donald Min

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision PYRIDOSTIGMINE BROMIDE ORAL SOLUTION PF 44(2) Pg. ONLINE Pyridostigmine Related Compound B RS Claire Chisolm 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 Pyridostigmine Bromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine New PYRIDOSTIGMINE BROMIDE EXTENDED-RELEASE TABLETS PF 44(2) Pg. ONLINE Related Compound B RS Claire Chisolm Title, Chemical Info/Chemical Structure, Chemical Info/C24H33N3O4, Chemical Info/427.55, Chemical Info/1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2- hydroxy-3-(2-methoxyphenoxy)propyl]-,(±)-;, Chemical Info/N-(2,6-Dimethylphenyl)- 4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-piperazin-1-ylacetamide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ranolazine Related Compound A, IMPURITIES/Limit of Epichlorohydrin, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Guaifenesin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP p-Ranolazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP New RANOLAZINE PF 44(3) Pg. ONLINE Reference Standards <11>/USP Ranolazine Related Compound D RS Donald Min 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 Guaifenesin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP p-Ranolazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ranolazine New RANOLAZINE EXTENDED-RELEASE TABLETS PF 44(3) Pg. ONLINE Related Compound C RS Donald Min IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Revision ROPINIROLE TABLETS PF 44(2) Pg. ONLINE IMPURITIES/Organic Impurities 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 Title, DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/⧫, SPECIFIC TESTS/⧫, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, Revision SACCHARIN PF 44(2) Pg. ONLINE ADDITIONAL REQUIREMENTS/⧫ Tong Liu DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Color of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP o-Toluenesulfonamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP p- Revision SACCHARIN CALCIUM PF 44(2) Pg. ONLINE Toluenesulfonamide RS Tong Liu

Title, DEFINITION/Introduction, IDENTIFICATION/⧫, ASSAY/Procedure, IMPURITIES/⧫, SPECIFIC TESTS/Readily Carbonizable Substances Test <271>, SPECIFIC TESTS/Color of Solution, ADDITIONAL REQUIREMENTS/⧫, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP o-Toluenesulfonamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP p- Revision SACCHARIN SODIUM PF 44(2) Pg. ONLINE Toluenesulfonamide RS Tong Liu 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

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., IDENTIFICATION/D., ASSAY/Procedure 1: Sitagliptin, ASSAY/Procedure 2: Metformin Hydrochloride, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities: Sitagliptin, IMPURITIES/Organic Impurities: Metformin Hydrochloride, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metformin Hydrochloride RS, SITAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS PF ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sitagliptin New 44(3) Pg. ONLINE Phosphate RS Andrea Carney Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., IDENTIFICATION/D., ASSAY/Procedure 1: Sitagliptin, ASSAY/Procedure 2: Metformin Hydrochloride, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities: Sitagliptin, IMPURITIES/Organic Impurities: Metformin Hydrochloride, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metformin Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sitagliptin New SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS PF 44(3) Pg. ONLINE Phosphate RS Andrea Carney

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 Revision SODIUM LAUROYL SARCOSINATE PF 43(4) Pg. ONLINE Standards <11>/USP 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 REQUIREMENTS/USP Reference Standards Revision SODIUM MONOFLUOROPHOSPHATE PF 43(4) Pg. ONLINE <11>/USP Sodium Sulfate RS Michael Chang

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., 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/USP Reference Standards <11>/USP Sodium Phenylbutyrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylbutyrate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New SODIUM PHENYLBUTYRATE ORAL POWDER PF 44(2) Pg. ONLINE <11>/USP Phenylbutyrate Related Compound B RS Behnaz Almasi

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 Sodium Phenylbutyrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylbutyrate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New SODIUM PHENYLBUTYRATE TABLETS PF 44(2) Pg. ONLINE <11>/USP Phenylbutyrate Related Compound B RS Behnaz Almasi 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

Title, Chemical Info/Chemical Structure, Chemical Info/C21H16ClF3N4O3·C7H8O3S, Chemical Info/637.03, Chemical Info/2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3- (trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-, mono(4- methylbenzenesulfonate);, Chemical Info/4-(4-{3-[4-Chloro-3- (trifluoromethyl)phenyl]ureido}phenoxy)-N2-methylpyridine-2-carboxamide mono(4- methylbenzenesulfonate), Chemical Info/CAS, Chemical Info/Sorafenib (free base), Chemical Info/C21H16ClF3N4O3, Chemical Info/464.83, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sorafenib Tosylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New SORAFENIB TOSYLATE PF 44(3) Pg. ONLINE Sorafenib Related Compound H RS Feiwen Mao Chemical Info/2,4-Hexadienoic acid, (E,E)-; 2,4-Hexadienoic acid;(2E,4E)-Hexa-2,4- dienoic acid;, Chemical Info/(E,E)-Sorbic acid Sorbic acid, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or<197K>, ASSAY/Procedure, Revision SORBIC ACID PF 44(2) Pg. ONLINE IMPURITIES/Limit of Aldehyde Peng Zhang

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Revision SPIRONOLACTONE TABLETS PF 44(2) Pg. ONLINE Compound B RS Donald Min

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 Revision TERBUTALINE SULFATE TABLETS PF 44(1) Pg. ONLINE Terbutaline Related Compound A RS Ren-Hwa Yeh IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Cypionate Related Revision TESTOSTERONE CYPIONATE INJECTION PF 44(2) Pg. ONLINE Compound B 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 Title, Chemical Info/Chemical Structure, Chemical Info/C19H27NO3, Chemical Info/317.42, Chemical Info/2-H-Benzo[a]quinolizin-2-one, 1,3,4,6,7,11b-hexahydro- 9,10-dimethoxy-3-(2-methylpropyl)-;, Chemical Info/(3RS,11bRS)-3-Isobutyl-9,10- dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetrabenazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetrabenazine Related New TETRABENAZINE PF 44(3) Pg. ONLINE Compound C RS Sridevi Ramachandran

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, Chemical Info/Chemical Structure, Chemical Info/C16H28N4O8, Chemical Info/404.42, Chemical Info/1,4,7,10-Tetraazacyclododecane-1,4,7,10-tetraacetic acid;, Chemical Info/2,2′,2′′,2′′′-(1,4,7,10- Tetraazacyclododecane-1,4,7,10-tetryl)tetraacetic acid., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetraxetan RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetraxetan Related Compound A New TETRAXETAN PF 44(3) Pg. ONLINE RS Ravi Ravichandran 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, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Revision TRIAMCINOLONE ACETONIDE LOTION PF 44(3) Pg. ONLINE Standards <11>/USP Triamcinolone 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, IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triamcinolone Acetonide Related Revision TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION PF 44(3) Pg. ONLINE Compound C RS Ren-Hwa Yeh

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 Elena Curti New UNDECANOIC ACID PF 42(4) Pg. ONLINE Undecanoic Acid Hong Wang Title, DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, New VANCOMYCIN HYDROCHLORIDE COMPOUNDED ORAL SOLUTION PF 44(2) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Vancomycin B RS Jeanne Sun 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

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, 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/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum indicum Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Linarin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Luteolin 7-O- New WILD CHRYSANTHEMUM FLOWER PF 44(2) Pg. ONLINE Glucoside RS Cuiying Ma Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, 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/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorogenic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum indicum Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chrysanthemum × morifolium Flower Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isochlorogenic Acid A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Linarin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Luteolin 7-O- New WILD CHRYSANTHEMUM FLOWER DRY EXTRACT PF 44(2) Pg. ONLINE Glucoside RS Cuiying Ma