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Compendial Cancellations for USP42-NF37 1S

Category Monograph Title Monograph Section Scientific Liaison

Title, INTRODUCTION, IDENTIFICATION OF IMPURITIES AND DEGRADATION PRODUCTS, ANALYTICAL PROCEDURES FOR IMPURITIES AND DEGRADATION PRODUCTS, REPORTING IMPURITIES AND DEGRADATION PRODUCTS, SETTING ACCEPTANCE CRITERIA FOR IMPURITIES AND DEGRADATION PRODUCTS, <476> CONTROL OF ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG QUALIFICATION OF IMPURITIES AND DEGRADATION PRODUCTS, ORGANIC Revision PRODUCTS PF 43(6) Pg. ONLINE IMPURITIES IN DRUG SUBSTANCES, ORGANIC IMPURITIES IN DRUG PRODUCTS Antonio Hernandez-Cardoso

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 <601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND AEROSOLS AND SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION- Revision POWDERS--PERFORMANCE QUALITY TESTS PF 42(6) Pg. ONLINE INHALATION AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi

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

INTRODUCTION, QUALIFICATION OF UV-VIS SPECTROMETERS, PROCEDURE, Revision <857> ULTRAVIOLET-VISIBLE SPECTROSCOPY PF 43(5) Pg. ONLINE VALIDATION AND VERIFICATIONVERIFICATION AND VALIDATION Margareth Marques Title, Introduction, QUALIFICATION OF RAMAN SPECTROMETERS, PROCEDURE, New <858> RAMAN SPECTROSCOPY PF 43(4) Pg. ONLINE VALIDATION AND VERIFICATION, VERIFICATION, Title Kahkashan Zaidi

INTRODUCTION, REGULATORY CONSIDERATIONS, IMPACT OF ANCILLARY MATERIAL QUALITY ON PRODUCT QUALITY, QUALIFICATION OF ANCILLARY MATERIALS, RISK <1043> ANCILLARY MATERIALS FOR CELL, GENE AND TISSUE ENGINEERED CLASSIFICATIONMANAGEMENT, PERFORMANCE TESTING, ANCILLARY MATERIALS Revision PRODUCTS PF 43(4) Pg. ONLINE RESIDUAL LEVELRESIDUAL ASSESSMENT AND REMOVAL, CONCLUSION, APPENDIX Fouad Atouf

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

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

Title, Introduction, INTRODUCTION, THEORY, QUALITATIVE AND QUANTITATIVE RAMAN MEASUREMENTS, FACTORS AFFECTING QUANTIFICATION, SAMPLING FACTORS, APPARATUS, QUALIFICATION AND VERIFICATION OF RAMAN SPECTROMETERS, SPECIALIZED TECHNIQUES, METHOD VALIDATION, PROCEDURE VALIDATION, DEFINITION OF TERMS AND SYMBOLS, CALIBRATION, FACTORS THAT Revision <1120> RAMAN SPECTROSCOPY PF 40(6) Pg. ONLINE AFFECT MEASUREMENT PERFORMANCE Kahkashan Zaidi New AFLATOXIN G1 PF 44(1) Pg. ONLINE Aflatoxin G1, Maria Monagas New AFLATOXIN B2 PF 44(1) Pg. ONLINE Aflatoxin B2, Maria Monagas New AFLATOXIN B1 PF 44(1) Pg. ONLINE Aflatoxin B1, Maria Monagas New AFLATOXIN G2 PF 44(1) Pg. ONLINE Aflatoxin G2, Maria Monagas ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound H Revision AMOXICILLIN FOR ORAL SUSPENSION PF 42(6) Pg. ONLINE RS Ramanujam Prasad AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION PF 44(3) Pg. IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Revision ONLINE Impurities Ramanujam Prasad

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compounds D and E Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS PF 44(3) Pg. ONLINE Amoxicillin Related Compound G RS Ramanujam Prasad

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 RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Acetate Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Revision BETAMETHASONE ACETATE PF 42(5) Pg. ONLINE Standards <11>/USP Acetate RS Mary Koleck

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New BUDESONIDE DELAYED-RELEASE CAPSULES PF 42(5) Pg. ONLINE <11>/USP Budesonide Related Compound L RS Mary Koleck 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/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cromolyn Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cromolyn Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cromolyn Related Compound B New CROMOLYN SODIUM ORAL SOLUTION PF 44(3) Pg. ONLINE RS Mary Koleck

Chemical Info/Chemical NameC46H64N14O12S2·xC2H4O2·yH2O 1069.22 (anhydrous, free base) Vasopressin, 1-(3-mercaptopropanoic acid)-8-d-arginine-, acetate (salt) hydrate; 1-(3-Mercaptopropionic acid)-8-d-arginine-vasopressin, acetate (salt) hydrate. x(acetate), y(water). Monoacetate trihydrate62357-86-2 Monoacetate anhydrous62288-83-9Chemical Info/CAS, IDENTIFICATION/Mass Spectral Analysis, ASSAY/Procedure, IMPURITIES/Desmopressin-Related Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, Revision DESMOPRESSIN ACETATE PF 44(2) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxytocin RS Elena Curti New DESVENLAFAXINE SUCCINATE PF 43(5) Pg. ONLINE SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation Heather Joyce OTHER COMPONENTS/Content of Dimethyl Sulfoxide (if present), OTHER New DICLOFENAC SODIUM TOPICAL SOLUTION PF 44(1) Pg. ONLINE COMPONENTS/Content of Ethanol (if present) Wei Yang Title, Chemical Info/Chemical Structure, Chemical Info/C16H15N3·HCl, Chemical Info/285.78, Chemical Info/1H-Dibenzo[c,f]imidazo[1,5-a]azepin-3-amine, 9,13b- dihydro-, hydrochloride;, Chemical Info/3-Amino-9,13b-dihydro-1H- dibenz[c,f]imidazo[1,5-a]azepine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epinastine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New EPINASTINE HYDROCHLORIDE PF 43(2) Pg. ONLINE Epinastine Related Compound A RS Gerald Hsu Revision Eriochrome Black T PF 43(5) Pg. ONLINE Eriochrome Black T Margareth Marques

Title, Chemical Info/Chemical Structure, Chemical Info/C22H24N3NaO7S, Chemical Info/497.50, Chemical Info/1-Azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 3-[[5-[[(3- carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7- oxo-, monosodium salt, [4R-[3(3S*,5S*), 4α,5β,6β(R*)]]-;, Chemical Info/(4R,5S,6S)-3-[[(3S,5S)-5-[(m-Carboxyphenyl)carbamoyl]-3-pyrrolidinyl]thio]-6- [(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, monosodium salt, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference New ERTAPENEM SODIUM PF 44(1) Pg. ONLINE Standards <11>/USP Ertapenem Sodium RS Ramanujam Prasad Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluvastatin Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluvastatin for New FLUVASTATIN EXTENDED-RELEASE TABLETS PF 42(4) Pg. ONLINE System Suitability RS Sujatha Ramakrishna

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Maleic Acid and Malic Acid, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Glacial Acetic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lactic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Malic Acid RS, Revision FUMARIC ACID PF 43(5) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Succinic Acid RS Galina Holloway IDENTIFICATION/B., SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Revision HARD GELATIN CAPSULE SHELL PF 43(6) Pg. ONLINE Specified Microorganisms <62> Margareth Marques IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, Revision GUANFACINE HYDROCHLORIDE PF 44(3) Pg. ONLINE IMPURITIES/Organic Impurities, Procedure 2 Edith Chang

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

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Solvents, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation, SPECIFIC TESTS/Loss on Drying, SPECIFIC TESTS/Water Revision IMIPENEM PF 43(3) Pg. ONLINE Determination <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage Ramanujam Prasad New LEUCOVORIN CALCIUM FOR INJECTION PF 42(5) Pg. ONLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Feiwen Mao

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 Related Compound C RS 6,13aβ-Dimethyl-3,17-dioxo- 13(17)a-homoandrosta-4,6-diene-13a-yl acetate.(C24H34O4386.52 ) USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene-17-yl acetate.(C24H32O4384.51 ) USP Megestrol Acetate Related Compound H RS Revision MEGESTROL ACETATE PF 42(6) Pg. ONLINE 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4398.54 ) Gerald Hsu

DEFINITION/Introduction, IDENTIFICATION/<197S>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Revision METHOHEXITAL PF 42(5) Pg. ONLINE Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Gerald Hsu IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Revision METHOHEXITAL SODIUM FOR INJECTION PF 42(5) Pg. ONLINE IMPURITIES/Organic Impurities Gerald Hsu IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naproxen Related Compound L Revision NAPROXEN ORAL SUSPENSION PF 42(4) Pg. ONLINE RS Sujatha Ramakrishna ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxetine Related Revision OLANZAPINE AND FLUOXETINE CAPSULES PF 42(5) Pg. ONLINE Compound B RS Gerald Hsu

IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Revision PHENTOLAMINE MESYLATE PF 43(3) Pg. ONLINE Standards <11>/USP Phentolamine Amine Analog RS Donald Min

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

DEFINITION/Introduction, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Calcium, IMPURITIES/Limit of Iron, Selenium, and Aluminum, IMPURITIES/Limit of Chloride, Sulfate, and Sulfite, IMPURITIES/Limit of Sulfide, IMPURITIES/Limit of Zinc, IMPURITIES/Limit of Carbonate, IMPURITIES/Nitrogen Compounds, IMPURITIES/Total Non-Purgeable Organic Carbon Content, SPECIFIC TESTS/Insoluble Matter, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61>, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Sulfate Anhydrous RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sodium Sulfide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Revision SODIUM THIOSULFATE PF 44(2) Pg. ONLINE Sucrose RS Donald Min IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Epimer Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Spironolactone Revision SPIRONOLACTONE PF 42(1) Pg. ONLINE Related Compound I RS Donald Min

IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Free Cyclopentanepropionic Acid, IMPURITIES/Limit of Cyclopentanepropionic Acid, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclopentylpropanoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Testosterone Cypionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Revision TESTOSTERONE CYPIONATE PF 44(2) Pg. ONLINE Standards <11>/USP Testosterone Cypionate Related Compound B RS Ren-Hwa Yeh

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

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

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

DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Particulate Matter in Injections <788>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP New ZINC SULFATE COMPOUNDED INJECTION PF 41(2) Pg. ONLINE Reference Standards <11>/USP Zinc Sulfate RS Jeanne Sun