Compendial Deferrals for USP42-NF37

Category Monograph Title Monograph Section Scientific Liaison

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

{Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent}, {Flavors and Fragrance} Neohesperidin Dihydrochalcone NF, {Sweetening Agent} Neohesperidin Dihydrochalcone NF Hong Wang

Revision GENERAL NOTICES TO USP-NF PF 44(1) Pg. ONLINE 2. OFFICIAL STATUS AND LEGAL RECOGNITION Jessica Simpson

Revision DESCRIPTION AND SOLUBILITY PF 43(4) Pg. ONLINE

Climbazole, Ropivacaine, Iscotrizinol, Trientine Hydrochloride, Sodium Lauroyl Sarcosinate, Epinastine Hydrochloride, Guanidine Hydrochloride, Desvenlafaxine, Desvenlafaxine Fumarate, Desvenlafaxine Succinate, Gadobutrol, Rotigotine, Benzphetamine Hydrochloride, Deferasirox, Eletriptan Hydrobromide, Milnacipran Hydrochloride, Neohesperidin Dihydrochalcone Sujatha Ramakrishna

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

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

Revision <121> INSULIN ASSAYS PF 43(4) Pg. ONLINE

??UNKNOWN??/Rabbit Blood Sugar Method-Quantitative, ??UNKNOWN??/In Vivo Bioidentity Test, ??UNKNOWN??/In Vitro Cell-Based Bioidentity Test for Insulin Glargine and Insulin Lispro Diane McCarthy

Revision<476> CONTROL OF ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 43(6) Pg. ONLINE

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

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

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

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

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

New <621> CHROMATOGRAPHY PF 43(5) Pg. ONLINEDEFINITIONS, SYSTEM SUITABILITY, ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS, QUANTIFICATION Horacio Pappa

Revision <785> OSMOLALITY AND OSMOLARITY PF 43(5) Pg. ONLINEINTRODUCTION, OSMOTIC PRESSUREBACKGROUND, OSMOLALITYOPERATION AND CALIBRATION OF OSMOMETER, OSMOLARITY, MEASUREMENT OF OSMOLALITY Margareth Marques

New <856> NEAR-INFRARED SPECTROSCOPY PF 43(4) Pg. ONLINE

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

Revision <857> ULTRAVIOLET-VISIBLE SPECTROSCOPY PF 43(5) Pg. ONLINEINTRODUCTION, QUALIFICATION OF UV-VIS SPECTROMETERS, PROCEDURE, VALIDATION AND VERIFICATIONVERIFICATION AND VALIDATION Margareth Marques

New <858> RAMAN SPECTROSCOPY PF 43(4) Pg. ONLINETitle, Introduction, QUALIFICATION OF RAMAN SPECTROMETERS, PROCEDURE, VALIDATION AND VERIFICATION, VERIFICATION, Title Kahkashan Zaidi

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

Revision<1043> ANCILLARY MATERIALS FOR CELL, GENE AND TISSUE ENGINEERED PRODUCTS PF 43(4) Pg. ONLINE

INTRODUCTION, REGULATORY CONSIDERATIONS, IMPACT OF ANCILLARY MATERIAL QUALITY ON PRODUCT QUALITY, QUALIFICATION OF ANCILLARY MATERIALS, RISK CLASSIFICATIONMANAGEMENT, PERFORMANCE TESTING, ANCILLARY MATERIALS RESIDUAL LEVELRESIDUAL ASSESSMENT AND REMOVAL, CONCLUSION, APPENDIX Fouad Atouf

Revision<1057> BIOTECHNOLOGY-DERIVED ARTICLES -- TOTAL PROTEIN ASSAY PF 44(1) Pg. ONLINE

Introduction, INTRODUCTION, SAMPLE EXTRACTION METHODS FOR TOTAL PROTEIN ASSAYS, TOTAL PROTEIN MEASUREMENT PROCEDURES Elena Curti

Revision<1086> IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 43(6) Pg. ONLINE

INTRODUCTION, DRUG SUBSTANCE, DRUG PRODUCT, ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS, ORGANIC IMPURITIES DECISION TREE, TERMINOLOGY ASSOCIATED WITH ORGANIC IMPURITIES USED IN DRUG SUBSTANCE AND DRUG PRODUCT MONOGRAPHS, APPENDIX 1:GLOSSARY, APPENDIX 2: ADDITIONAL SOURCES OF INFORMATION AND GUIDANCE Antonio Hernandez-Cardoso

Revision <1119> NEAR-INFRARED SPECTROSCOPY PF 43(4) Pg. ONLINE

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

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

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

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

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

Revision ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS PF 43(5) Pg. ONLINE

IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Codeine N-Oxide RS Wei Yang

Revision ACETAZOLAMIDE PF 43(4) Pg. ONLINEIMPURITIES/Silver-Reducing Substances, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities Feiwen Mao

New AFLATOXIN G1 PF 44(1) Pg. ONLINE Aflatoxin G1, Maria MonagasNew AFLATOXIN B2 PF 44(1) Pg. ONLINE Aflatoxin B2, Maria MonagasNew AFLATOXIN B1 PF 44(1) Pg. ONLINE Aflatoxin B1, Maria MonagasNew AFLATOXIN G2 PF 44(1) Pg. ONLINE Aflatoxin G2, Maria Monagas

New ALBUTEROL INHALATION AEROSOL PF 44(1) Pg. ONLINE

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 <11>/USP Levalbuterol Related Compound D RS Ravi Ravichandran

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

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

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

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

New ALOSETRON HYDROCHLORIDE PF 43(2) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C17H18N4O·HCl, Chemical Info/330.82, Chemical Info/1H-Pyrido[4,3-b]indol-1-one, 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-, hydrochloride;, Chemical Info/2,3,4,5-Tetrahydro-5-methyl-2-[(5-methylimidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Related Compound A RS Andrea Carney

New ALOSETRON TABLETS PF 43(2) Pg. ONLINE

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

Revision AMANTADINE HYDROCHLORIDE PF 43(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/<197S>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Clarity and Color of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amantadine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amantadine Related Compound B RS Shankari Shivaprasad

Revision AMANTADINE HYDROCHLORIDE CAPSULES PF 43(4) Pg. ONLINE

IDENTIFICATION/A.Infrared Absorption <197S> <197>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ Shankari Shivaprasad

Revision AMANTADINE HYDROCHLORIDE ORAL SOLUTION PF 43(4) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197S><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amantadine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amantadine Related Compound B RS Shankari Shivaprasad

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

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

Revision AMPICILLIN AND SULBACTAM FOR INJECTION PF 44(1) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ampicillin System Suitability Mixture RS Ramanujam Prasad

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

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

Revision ASPIRIN PF 41(6) Pg. ONLINE

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

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

New AZACITIDINE PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C8H12N4O5, Chemical Info/244.20, Chemical Info/1,3,5-Triazin-2(1H)-one, 4-amino-1-&beta;-d-ribofuranosyl-;, Chemical Info/4-Amino-1-&beta;-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-&beta;-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 Standards <11>/USP Azacitidine Related Compound C RS Feiwen Mao

Revision AZATHIOPRINE TABLETS PF 43(3) Pg. ONLINE

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

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

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

Revision BENZONATATE PF 44(1) Pg. ONLINE

Chemical Info/Chemical NameChemical Info/Chemical StructureChemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetracaine Related Compound B RS Wei Yang

New BENZPHETAMINE HYDROCHLORIDE PF 43(3) Pg. ONLINE

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

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

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

Revision BETAMETHASONE ACETATE PF 42(5) Pg. ONLINE

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

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

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

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

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

Revision BETAXOLOL HYDROCHLORIDE PF 43(6) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betaxolol Related Compound A RS Feiwen Mao

Revision BETAXOLOL TABLETS PF 43(6) Pg. ONLINE

IDENTIFICATION/B, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betaxolol Related Compound A RS Feiwen Mao

New BITTER ORANGE FRUIT FLAVONOIDS DRY EXTRACT PF 44(1) Pg. ONLINE

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 REQUIREMENTS/USP Reference Standards <11>/USP Neohesperidin RS Maria Monagas

Revision BROMOCRIPTINE MESYLATE CAPSULES PF 43(6) Pg. ONLINEIDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Mary Koleck

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

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

Revision BUMETANIDE PF 44(1) Pg. ONLINE

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-(butylamino)-4-phenoxy-5-sulfamoylbenzoate RS Edith Chang

Revision BUMETANIDE INJECTION PF 44(1) Pg. ONLINE

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 Standards <11>/USP Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate RS Edith Chang

Revision BUMETANIDE TABLETS PF 43(6) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bumetanide Related Compound B RS Edith Chang

Revision CAFFEINE CITRATE INJECTION PF 43(6) Pg. ONLINE

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 Theophylline RS Heather Joyce

New CALCIPOTRIENE TOPICAL SOLUTION PF 43(6) Pg. ONLINE

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 C RS Feiwen Mao

Revision CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLETS PF 43(4) Pg. ONLINE

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 Disulfide RS Edith Chang

Revision CARBIDOPA AND LEVODOPA ORALLY DISINTEGRATING TABLETS PF 44(1) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Heather Joyce

Revision LOW-SUBSTITUTED CARBOXYMETHYLCELLULOSE SODIUM PF 43(6) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Tong Liu

Revision CEFIXIME PF 44(1) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation Slavica Shane

New CEFIXIME CAPSULES PF 44(1) Pg. ONLINE

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 Standards <11>/USP Cefixime RS Slavica Shane

Revision CEFIXIME FOR ORAL SUSPENSION PF 44(1) Pg. ONLINE

IDENTIFICATION/ A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> Slavica Shane

Revision CEFIXIME TABLETS PF 44(1) Pg. ONLINE

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 Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Slavica Shane

Revision CEFOTETAN FOR INJECTION PF 43(6) Pg. ONLINE

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 <11>/USP Endotoxin RS Slavica Shane

Revision CEFOTETAN DISODIUM PF 43(6) Pg. ONLINE

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 <11>/USP Endotoxin RS Slavica Shane

Revision CELECOXIB PF 43(6) Pg. ONLINE

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 Reference Standards <11>/USP Sulfanilamide RS Wei Yang

New CELECOXIB CAPSULES PF 43(3) Pg. ONLINE

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

Revision CEPHALEXIN PF 43(6) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, IMPURITIES/Procedure 2, ADDITIONAL REQUIREMENTS/Labeling Slavica Shane

Revision CEPHALEXIN CAPSULES PF 43(6) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Slavica Shane

Revision CEPHALEXIN FOR ORAL SUSPENSION PF 43(6) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Slavica ShaneNew CHELATING ION EXCHANGE RESIN PF 41(3) Pg. ONLINE Chelating Ion-Exchange Resin Trish Li

Revision CHLORHEXIDINE GLUCONATE TOPICAL GEL PF 43(6) Pg. ONLINE

IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/C. Thin-Layer Chromatographic Identification Test <201>, ASSAY/Procedure, IMPURITIES/Limit of p-Chloroaniline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorhexidine System Suitability Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Potassium Gluconate RS Sujatha Ramakrishna

New CHLOROMETHYLNITROIMIDAZOLE PF 43(3) Pg. ONLINE Chloromethylnitroimidazole Sridevi Ramachandran

Revision CHLORZOXAZONE PF 43(4) Pg. ONLINE

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 Temperature <741> Heather Joyce

Revision CHLORZOXAZONE TABLETS PF 43(4) Pg. ONLINE

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

New CHOLINE FENOFIBRATE PF 42(6) Pg. ONLINE

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

New CLIMBAZOLE PF 43(4) Pg. ONLINE

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 REQUIREMENTS/USP Reference Standards <11>/USP Climbazole RS Sujatha Ramakrishna

Revision CLOMIPHENE CITRATE TABLETS PF 43(4) Pg. ONLINE

IDENTIFICATION/Identification-Organic Nitrogenous Bases <181>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Mary Koleck

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

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

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

New DEFERASIROX PF 43(3) Pg. ONLINE

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

New DESVENLAFAXINE PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C16H25NO2, Chemical Info/263.38, Chemical Info/4-[2-(Dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol;, Chemical Info/1-[2-(Dimethylamino)-1-(4-hydroxyphenyl)ethyl]cyclohexanol hydrogen, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Desvenlafaxine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Desvenlafaxine Related Compound A RS 4-[1-(Cyclohex-1-en-1-yl)-2-(dimethylamino)ethyl]phenol.C16H23NO245.37, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Venlafaxine Hydrochloride RS Heather Joyce

New DESVENLAFAXINE FUMARATE PF 43(5) Pg. ONLINE

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

New DESVENLAFAXINE SUCCINATE PF 43(5) Pg. ONLINE

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

New DESVENLAFAXINE EXTENDED-RELEASE TABLETS PF 44(1) Pg. ONLINE

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 <11>/USP Venlafaxine Hydrochloride RS Heather Joyce

Revision DEXAMETHASONE PF 42(4) Pg. ONLINE

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

Revision DEXAMETHASONE ELIXIR PF 43(6) Pg. ONLINE

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

Revision DEXAMETHASONE ORAL SOLUTION PF 43(6) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methylparaben RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Prednisolone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Propylparaben RS Mary Koleck

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

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

Revision DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION PF 43(6) Pg. ONLINE

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

Revision DEXTROMETHORPHAN PF 43(5) Pg. ONLINE

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 Reference Standards <11>/USP Dextromethorphan Related Compound C RS Clydewyn Anthony

Revision DEXTROMETHORPHAN HYDROBROMIDE PF 43(5) Pg. ONLINE

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 Standards <11>/USP Dextromethorphan Related Compound C RS Clydewyn Anthony

New DICLOFENAC SODIUM TOPICAL SOLUTION PF 44(1) Pg. ONLINE

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

Revision DICYCLOMINE HYDROCHLORIDE PF 43(6) Pg. ONLINE

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

Revision DICYCLOMINE HYDROCHLORIDE CAPSULES PF 43(6) Pg. ONLINE

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 Dicyclomine Related Compound A RS Behnaz Almasi

Revision DICYCLOMINE HYDROCHLORIDE INJECTION PF 43(6) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Limit of Dicyclomine Related Compound A, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Behnaz Almasi

Revision DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION PF 43(6) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi

Revision DICYCLOMINE HYDROCHLORIDE TABLETS PF 43(6) Pg. ONLINE

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 Dicyclomine Related Compound A RS Behnaz Almasi

Revision DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES PF 43(5) Pg. ONLINE PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Clydewyn Anthony

Revision DIPHENHYDRAMINE HYDROCHLORIDE ORAL SOLUTION PF 43(5) Pg. ONLINE

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 REQUIREMENTS/USP Reference Standards <11>/USP Diphenhydramine N-Oxide RS Clydewyn Anthony

New DIPHENHYDRAMINE HYDROCHLORIDE TABLETS PF 43(4) Pg. ONLINE

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 Reference Standards <11>/USP Diphenhydramine N-Oxide RS Clydewyn Anthony

RevisionDIPHENHYDRAMINE AND PHENYLEPHRINE HYDROCHLORIDES TABLETS PF 43(5) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Clydewyn Anthony

New DIPHENHYDRAMINE HYDROCHLORIDE ORAL POWDER PF 43(5) Pg. ONLINE

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 Reference Standards <11>/USP Diphenhydramine N-Oxide RS Clydewyn Anthony

Revision DISULFIRAM PF 43(6) Pg. ONLINE

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 I <741> Heather Joyce

Revision DOBUTAMINE HYDROCHLORIDE PF 43(6) Pg. ONLINE

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 Standards <11>/USP Raspberry Ketone RS Edith Chang

New DONG QUAI ROOT PF 43(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Volatile Oil Determination, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination <921>, Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Angelica sinensis Root Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Z-Ligustilide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Senkyunolide A RS Cuiying Ma

New DONG QUAI ROOT POWDER PF 43(5) Pg. ONLINE

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 Reference Standards <11>/USP Senkyunolide A RS Cuiying Ma

New ELETRIPTAN HYDROBROMIDE PF 43(3) Pg. ONLINE

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

Revision EPHEDRINE PF 43(5) Pg. ONLINE

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 REQUIREMENTS/USP Reference Standards <11>/USP Pseudoephedrine Sulfate RS Clydewyn Anthony

Revision EPHEDRINE SULFATE PF 43(5) Pg. ONLINE

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 <11>/USP Pseudoephedrine Sulfate RS Clydewyn Anthony

New EPINASTINE HYDROCHLORIDE PF 43(2) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C16H15N3·HCl, Chemical Info/285.78, Chemical Info/1H-Dibenzo[c,f]imidazo[1,5-a]azepin-3-amine, 9,13b-dihydro-, hydrochloride;, Chemical Info/3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinastine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinastine Related Compound A RS Gerald Hsu

Revision EPINEPHRINE PF 42(6) Pg. ONLINE

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

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

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

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

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

Revision Eriochrome Black T PF 43(5) Pg. ONLINE Eriochrome Black T Margareth Marques

New ERTAPENEM SODIUM PF 44(1) Pg. ONLINE

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

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

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

Revision ETHAMBUTOL HYDROCHLORIDE PF 43(6) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K><197>, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Aminobutanol, SPECIFIC TESTS/Limit of Total Stereoisomers Shankari Shivaprasad

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

New EVEROLIMUS PF 42(6) Pg. ONLINE

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

New FAMCICLOVIR TABLETS PF 44(1) Pg. ONLINE

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

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

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

Revision FENTANYL PF 44(1) Pg. ONLINE

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 Reference Standards <11>/USP Fentanyl Related Compound G RS Wei Yang

New FEXOFENADINE HYDROCHLORIDE ORAL SUSPENSION PF 43(6) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, 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 <11>/USP Propylparaben RS Gerald Hsu

Revision FLUOXETINE HYDROCHLORIDE PF 43(6) Pg. ONLINE IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities Heather Joyce

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

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

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

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

Revision FUMARIC ACID PF 43(5) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Maleic Acid and Malic Acid, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Glacial Acetic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lactic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Malic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Succinic Acid RS Galina Holloway

New GADOBUTROL PF 43(5) Pg. ONLINE

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&prime;5&prime;-(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 Mixture RS Ravi Ravichandran

Revision HARD GELATIN CAPSULE SHELL PF 43(6) Pg. ONLINEIDENTIFICATION/B., SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> Margareth Marques

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

New GUANIDINE HYDROCHLORIDE PF 43(4) Pg. ONLINE

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 <11>/USP Guanidine Hydrochloride RS Galina Holloway

Revision HISTIDINE PF 43(6) Pg. ONLINE

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 REQUIREMENTS/USP Reference Standards <11>/USP l-Lysine Hydrochloride RS Fatkhulla Tadjimukhamedov

Revision HYDROMORPHONE HYDROCHLORIDE PF 44(1) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Introduction, IMPURITIES/Organic Impurities, Procedure 1 Wei Yang

Revision HARD HYPROMELLOSE CAPSULE SHELL PF 44(1) Pg. ONLINE

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

Revision IFOSFAMIDE PF 43(6) Pg. ONLINE

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 REQUIREMENTS/USP Reference Standards <11>/USP Monoethanolamine RS Feiwen Mao

Revision IFOSFAMIDE FOR INJECTION PF 43(6) Pg. ONLINE

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 <11>/USP Monoethanolamine RS Feiwen Mao

New IFOSFAMIDE INJECTION PF 43(6) Pg. ONLINE

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 <11>/USP Ifosfamide Related Compound C RS Feiwen Mao

Revision IMIPENEM PF 43(3) Pg. ONLINE

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

Revision INAMRINONE INJECTION PF 44(1) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Lactic Acid Content, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Inamrinone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Inamrinone Related Compound C RS Edith Chang

New ISCOTRIZINOL PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C44H59N7O5, Chemical Info/765.98, Chemical Info/Benzoic acid, 4,4&prime;-[[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&prime;-[(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 Reference Standards <11>/USP Iscotrizinol Related Compound I RS Feiwen Mao

New ITRACONAZOLE CAPSULES PF 43(6) Pg. ONLINE

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

New L-ALPHA-GLYCERYLPHOSPHORYLCHOLINE PF 43(5) Pg. ONLINE

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-&alpha;-Glycerylphosphorylcholine, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Chloride, Sulfate, Phosphate, and Acetate, IMPURITIES/Limit of Glycerol, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests <2021>, SPECIFIC TESTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species, Test for Absence of Escherichia coli, and Test for Absence of Staphylococcus aureus, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Glycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-alpha-Glycerophosphorylethanolamine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-alpha-Glycerylphosphorylcholine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-alpha-Glycerylphosphorylcholine Solution RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP beta-Glycerylphosphorylcholine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Serine RS Huy Dinh

New L113 PF 43(4) Pg. ONLINE L113- Michael ChangNew L115 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex CarboPac PA100) Trish LiNew L116 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex DNAPac PA100) Trish Li

New LACOSAMIDE PF 43(6) Pg. ONLINE

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

New LACOSAMIDE INJECTION PF 43(6) Pg. ONLINE

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 RS Ren-Hwa Yeh

New LACOSAMIDE ORAL SOLUTION PF 43(6) Pg. ONLINE

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 Related Compound F RS Ren-Hwa Yeh

New LACOSAMIDE TABLETS PF 43(6) Pg. ONLINE

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

New LACTULOSE PF 43(3) Pg. ONLINE

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

Revision LEUCOVORIN CALCIUM PF 42(5) Pg. ONLINE

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

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

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

Revision LIDOCAINE OINTMENT PF 43(6) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lidocaine Related Compound H RS Richard Nguyen

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

Revision LIDOCAINE HYDROCHLORIDE JELLY PF 43(6) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lidocaine Related Compound H RS Richard Nguyen

Revision LIOTHYRONINE SODIUM PF 43(3) Pg. ONLINE

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

Revision LOPERAMIDE HYDROCHLORIDE PF 43(4) Pg. ONLINEASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Loperamide System Suitability Mixture RS Andrea Carney

Revision LOVASTATIN TABLETS PF 44(1) Pg. ONLINE

IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Mevastatin RS Donald Min

Revision MAGNESIUM HYDROXIDE PF 44(1) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Soluble Salts, IMPURITIES/Limit of Calcium, IMPURITIES/Limit of Lead, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang

Revision MAGNESIUM OXIDE PF 43(6) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Calcium, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang

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

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

Revision MALEIC ACID PF 43(5) Pg. ONLINE

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

Revision MEGESTROL ACETATE PF 42(6) Pg. ONLINE

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

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

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

New MESNA INJECTION PF 43(1) Pg. ONLINE

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

Revision METARAMINOL BITARTRATE PF 44(1) Pg. ONLINE

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 REQUIREMENTS/USP Reference Standards <11>/USP Metaraminol Enantiomer RS Donald Min

Revision METHOHEXITAL PF 42(5) Pg. ONLINE

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

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

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

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

New MILNACIPRAN HYDROCHLORIDE PF 43(3) Pg. ONLINE

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

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

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

Revision NALTREXONE HYDROCHLORIDE PF 43(6) Pg. ONLINE

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

Revision NAPROXEN PF 42(4) Pg. ONLINE

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

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

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

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

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

Revision NAPROXEN SODIUM PF 42(4) Pg. ONLINE

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

New NEOHESPERIDIN DIHYDROCHALCONE PF 43(6) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C28H36O15, Chemical Info/ 612.58, Chemical Info/1-Propanone, 1-[4-[[2-O-(6-deoxy-&alpha;-l-mannopyranosyl)-&beta;-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-(&alpha;-l-rhamnopyranosyl)-&beta;-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 Dihydrochalcone RS Peng Zhang

Revision NISOLDIPINE PF 43(6) Pg. ONLINE

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 <11>/USP Nisoldipine Related Compound G RS Donald Min

Revision NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS PF 43(6) Pg. ONLINE

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 Norethindrone Related Compound B RS Ren-Hwa Yeh

Revision NORGESTREL PF 43(6) Pg. ONLINE

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 Standards <11>/USP Norgestrel Related Compound L RS Ren-Hwa Yeh

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

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

Revision ORLISTAT CAPSULES PF 43(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Orlistat Related Compound D RS Hillary Cai

Revision OXAZEPAM CAPSULES PF 43(6) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Gerald Hsu

Revision OXYCODONE HYDROCHLORIDE PF 43(6) Pg. ONLINE

IDENTIFICATION/A. Procedure, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Limit of Alcohol, IMPURITIES/Note, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2: Limit of Oxycodone Related Compound A (14-Hydroxycodeinone) and Oxycodone Related Compound C (Codeinone), IMPURITIES/3, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Codeine Phosphate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxycodone Related Compound C RS Also known as Codeinone; 4,5&alpha;-Epoxy-3-methoxy-17-methylmorphinan-7-ene-6-one.C18H19NO3297.35 Hillary Cai

Revision PAMABROM PF 43(2) Pg. ONLINE

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

Revision PHENTOLAMINE MESYLATE PF 43(3) Pg. ONLINE

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

Revision PHENYLEPHRINE HYDROCHLORIDE INJECTION PF 43(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound F RS Hillary Cai

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

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

Revision PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 43(5) Pg. ONLINE

IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound G RS Clydewyn Anthony

New POLIDOCANOL PF 43(5) Pg. ONLINE

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), &alpha;-dodecyl-&omega;-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 Polidocanol RS Donald Min

New PRAMIPEXOLE DIHYDROCHLORIDE TABLETS PF 44(1) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/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 G RS Ravi Ravichandran

Revision PRAZOSIN HYDROCHLORIDE CAPSULES PF 43(5) Pg. ONLINE

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 Prazosin Hydrochloride RS Donald Min

Revision PRIMIDONE TABLETS PF 44(1) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Claire Chisolm

Revision PROGESTERONE PF 43(6) Pg. ONLINE

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 <11>/ Ren-Hwa Yeh

Revision PROGESTERONE INJECTION PF 43(6) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Progesterone System Suitability Mixture RS Ren-Hwa Yeh

Revision PROPRANOLOL HYDROCHLORIDE PF 43(6) Pg. ONLINE

DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class Ia <741>, SPECIFIC TESTS/Optical Rotation <781S>, Specific Rotation, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ USP Propranolol Related Compound A RS Donald Min

Revision PROPRANOLOL HYDROCHLORIDE INJECTION PF 44(1) Pg. ONLINE

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 Propranolol Related Compound A RS Donald Min

Revision PROPRANOLOL HYDROCHLORIDE TABLETS PF 43(6) Pg. ONLINE

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

Revision PROTRIPTYLINE HYDROCHLORIDE PF 43(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197M><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., IDENTIFICATION/D. X-Ray Diffraction <941>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791> Claire Chisolm

Revision PYRIDOSTIGMINE BROMIDE PF 44(1) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197A> or <197K>, IDENTIFICATION/Ultraviolet Absorption <197U>, IDENTIFICATION/C., IDENTIFICATION/D., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound B RS Claire Chisolm

New ROPIVACAINE PF 43(1) Pg. ONLINE

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

New ROTIGOTINE PF 43(5) Pg. ONLINE

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 Racemate RS Ravi Ravichandran

New ROTIGOTINE TRANSDERMAL SYSTEM PF 43(5) Pg. ONLINE

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 RS Ravi Ravichandran

Revision SALICYLIC ACID GEL PF 44(1) Pg. ONLINE

IDENTIFICATION/A. Procedure, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Clydewyn Anthony

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

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

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

Revision SERTRALINE HYDROCHLORIDE TABLETS PF 44(1) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities Claire Chisolm

New SICHUAN LOVAGE RHIZOME PF 43(4) Pg. ONLINE

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 REQUIREMENTS/USP Reference Standards <11>/USP Z-Ligustilide RS Cuiying Ma

New SICHUAN LOVAGE RHIZOME POWDER PF 43(4) Pg. ONLINE

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 Standards <11>/USP Z-Ligustilide RS Cuiying Ma

Revision SODIUM LAUROYL SARCOSINATE PF 43(4) Pg. ONLINE

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

Revision SODIUM MONOFLUOROPHOSPHATE PF 43(4) Pg. ONLINE

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 <11>/USP Sodium Sulfate RS Michael Chang

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

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

Revision SPIRONOLACTONE PF 42(1) Pg. ONLINE

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

Revision SULFAMETHOXAZOLE PF 43(6) Pg. ONLINE

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

New TACROLIMUS OINTMENT PF 43(3) Pg. ONLINE

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

Revision TERBUTALINE SULFATE PF 44(1) Pg. ONLINE

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 RS Ren-Hwa Yeh

Revision TERBUTALINE SULFATE INJECTION PF 44(1) Pg. ONLINE

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 RS Ren-Hwa Yeh

Revision TERBUTALINE SULFATE TABLETS PF 44(1) Pg. ONLINE

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

Revision TESTOSTERONE ENANTHATE PF 43(3) Pg. ONLINE

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

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

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

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

New TRANEXAMIC ACID TABLETS PF 43(6) Pg. ONLINE

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

Revision TRIAMCINOLONE ACETONIDE PF 43(5) Pg. ONLINE

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 Acetonide Related Compound C RS Ren-Hwa Yeh

Revision TRIAMCINOLONE ACETONIDE OINTMENT PF 43(5) Pg. ONLINE

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 Norethindrone RS Ren-Hwa Yeh

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

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

New TRIPTORELIN PAMOATE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C64H82N18O13 · C23H16O6, Chemical Info/1311.45 (free base), Chemical Info/6-d-Tryptophan-, 4,4&prime;-methylenebis[3-hydroxy-2-naphthalenecarboxylate] (salt);, Chemical Info/ 5-Oxo-l-prolyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosyl-d-tryptophyl-l-leucyl-l-arginyl-l-prolylglycine amide, 4,4\'-methylenebis[3-hydroxy-2-naphthoate] (salt)., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Amino Acid Analysis, IDENTIFICATION/C. HPLC, ASSAY/Procedure, OTHER COMPONENTS/Pamoic Acid Content, ??UNKNOWN??/Triptorelin-Related Impurities, ??UNKNOWN??/Acetic Acid, SPECIFIC TESTS/Water Determination <921>, Method I, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pamoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Triptorelin Related Compound C RS Dale Schmidt

Revision TRYPSIN PF 43(6) Pg. ONLINE

{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 Recombinant Porcine RS Diane McCarthy

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

Revision MICROCRYSTALLINE WAX PF 43(2) Pg. ONLINE

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

Revision WHITE WAX PF 42(2) Pg. ONLINE

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

Revision YELLOW WAX PF 42(2) Pg. ONLINE

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

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

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