Compendial Deferrals for USP42-NF37 Category Monograph Title Monograph Section Scientific Liaison {Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent}, {Flavors and Fragrance} Neohesperidin Revision EXCIPIENTS (USP and NF), LISTED BY CATEGORY PF 42(2) Pg. ONLINE Dihydrochalcone NF, {Sweetening Agent} Neohesperidin Dihydrochalcone NF Hong Wang Revision GENERAL NOTICES TO USP-NF PF 44(1) Pg. ONLINE 2. OFFICIAL STATUS AND LEGAL RECOGNITION Jessica Simpson Climbazole, Ropivacaine, Iscotrizinol, Trientine Hydrochloride, Sodium Lauroyl Sarcosinate, Epinastine Hydrochloride, Guanidine Hydrochloride, Desvenlafaxine, Desvenlafaxine Fumarate, Desvenlafaxine Succinate, Gadobutrol, Rotigotine, Benzphetamine Hydrochloride, Deferasirox, Eletriptan Hydrobromide, Milnacipran Revision DESCRIPTION AND SOLUBILITY PF 43(4) Pg. ONLINE Hydrochloride, Neohesperidin Dihydrochalcone Sujatha Ramakrishna Title, INTRODUCTION/Introduction, PROCEDURE/Identification, PROCEDURE/Enumeration, PERFORMANCE TESTS/, CONTAMINANTS/Introduction, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Storage, ADDITIONAL New <64> PROBIOTIC TESTS PF 43(2) Pg. ONLINE REQUIREMENTS/Labeling, ??UNKNOWN??/Introduction Seong Jae Yoo ??UNKNOWN??/Rabbit Blood Sugar Method-Quantitative, ??UNKNOWN??/In Vivo Bioidentity Test, ??UNKNOWN??/In Vitro Cell-Based Bioidentity Test for Insulin Glargine Revision <121> INSULIN ASSAYS PF 43(4) Pg. ONLINE and Insulin Lispro Diane McCarthy Title, INTRODUCTION, IDENTIFICATION OF IMPURITIES AND DEGRADATION PRODUCTS, ANALYTICAL PROCEDURES FOR IMPURITIES AND DEGRADATION PRODUCTS, REPORTING IMPURITIES AND DEGRADATION PRODUCTS, SETTING ACCEPTANCE CRITERIA FOR IMPURITIES AND DEGRADATION PRODUCTS, <476> CONTROL OF ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG QUALIFICATION OF IMPURITIES AND DEGRADATION PRODUCTS, ORGANIC Revision PRODUCTS PF 43(6) Pg. ONLINE IMPURITIES IN DRUG SUBSTANCES, ORGANIC IMPURITIES IN DRUG PRODUCTS Antonio Hernandez-Cardoso Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards New <509> RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE <11> Elena Curti TABLE OF CONTENTS, INTRODUCTION, A. DELIVERED-DOSE UNIFORMITYDELIVERED CONTENT UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS <601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND AND SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION-INHALATION Revision POWDERS--PERFORMANCE QUALITY TESTS PF 42(6) Pg. ONLINE AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi DEFINITIONS, SYSTEM SUITABILITY, ADJUSTMENT OF CHROMATOGRAPHIC New <621> CHROMATOGRAPHY PF 43(5) Pg. ONLINE CONDITIONS, QUANTIFICATION Horacio Pappa INTRODUCTION, OSMOTIC PRESSUREBACKGROUND, OSMOLALITYOPERATION AND Revision <785> OSMOLALITY AND OSMOLARITY PF 43(5) Pg. ONLINE CALIBRATION OF OSMOMETER, OSMOLARITY, MEASUREMENT OF OSMOLALITY Margareth Marques 1. INTRODUCTION, 2. QUALIFICATION OF NIR SPECTROMETERS, 3. PROCEDURE, 4. VALIDATION AND VERIFICATION, 1. INTRODUCTION, USP REFERENCE STANDARDS New <856> NEAR-INFRARED SPECTROSCOPY PF 43(4) Pg. ONLINE <11> Kahkashan Zaidi INTRODUCTION, QUALIFICATION OF UV-VIS SPECTROMETERS, PROCEDURE, Revision <857> ULTRAVIOLET-VISIBLE SPECTROSCOPY PF 43(5) Pg. ONLINE VALIDATION AND VERIFICATIONVERIFICATION AND VALIDATION Margareth Marques Title, Introduction, QUALIFICATION OF RAMAN SPECTROMETERS, PROCEDURE, New <858> RAMAN SPECTROSCOPY PF 43(4) Pg. ONLINE VALIDATION AND VERIFICATION, VERIFICATION, Title Kahkashan Zaidi <915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY New PENETROMETRY PF 43(2) Pg. ONLINE Title, INTRODUCTION, PROCEDURE, GLOSSARY Antonio Hernandez-Cardoso INTRODUCTION, REGULATORY CONSIDERATIONS, IMPACT OF ANCILLARY MATERIAL QUALITY ON PRODUCT QUALITY, QUALIFICATION OF ANCILLARY MATERIALS, RISK <1043> ANCILLARY MATERIALS FOR CELL, GENE AND TISSUE ENGINEERED CLASSIFICATIONMANAGEMENT, PERFORMANCE TESTING, ANCILLARY MATERIALS Revision PRODUCTS PF 43(4) Pg. ONLINE RESIDUAL LEVELRESIDUAL ASSESSMENT AND REMOVAL, CONCLUSION, APPENDIX Fouad Atouf <1057> BIOTECHNOLOGY-DERIVED ARTICLES -- TOTAL PROTEIN ASSAY PF 44(1) Pg. Introduction, INTRODUCTION, SAMPLE EXTRACTION METHODS FOR TOTAL PROTEIN Revision ONLINE ASSAYS, TOTAL PROTEIN MEASUREMENT PROCEDURES Elena Curti INTRODUCTION, DRUG SUBSTANCE, DRUG PRODUCT, ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS, ORGANIC IMPURITIES DECISION TREE, TERMINOLOGY ASSOCIATED WITH ORGANIC IMPURITIES USED IN DRUG SUBSTANCE <1086> IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 43(6) Pg. AND DRUG PRODUCT MONOGRAPHS, APPENDIX 1:GLOSSARY, APPENDIX 2: Revision ONLINE ADDITIONAL SOURCES OF INFORMATION AND GUIDANCE Antonio Hernandez-Cardoso 1. THEORY, 2. TRANSMISSION, REFLECTION, AND TRANSFLECTION MODES, 3. FACTORS THAT AFFECT NIR SPECTRA, 4. PRETREATMENT OF NIR SPECTRAL DATA, 5. INSTRUMENTATION, 6. APPLICATIONS, INTRODUCTION, INSTRUMENTATION, METHOD VALIDATION, GLOSSARY, *No Head*, 1. THEORY, 7. PROCEDURE VALIDATION, 8. Revision <1119> NEAR-INFRARED SPECTROSCOPY PF 43(4) Pg. ONLINE APPENDIX: GLOSSARY Kahkashan Zaidi Title, Introduction, INTRODUCTION, THEORY, QUALITATIVE AND QUANTITATIVE RAMAN MEASUREMENTS, FACTORS AFFECTING QUANTIFICATION, SAMPLING FACTORS, APPARATUS, QUALIFICATION AND VERIFICATION OF RAMAN SPECTROMETERS, SPECIALIZED TECHNIQUES, METHOD VALIDATION, PROCEDURE VALIDATION, DEFINITION OF TERMS AND SYMBOLS, CALIBRATION, FACTORS THAT Revision <1120> RAMAN SPECTROSCOPY PF 40(6) Pg. ONLINE AFFECT MEASUREMENT PERFORMANCE Kahkashan Zaidi New <1912> MEASUREMENT OF HARDNESS OF SEMISOLIDS PF 43(2) Pg. ONLINE Title, BACKGROUND, EXPERIMENTAL METHODS, GLOSSARY, REFERENCES Antonio Hernandez-Cardoso IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, Revision ACETAMINOPHEN TABLETS PF 42(3) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure Clydewyn Anthony IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Revision ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS PF 43(5) Pg. ONLINE Standards <11>/USP Codeine N-Oxide RS Wei Yang IMPURITIES/Silver-Reducing Substances, IMPURITIES/Ordinary Impurities <466>, Revision ACETAZOLAMIDE PF 43(4) Pg. ONLINE IMPURITIES/Organic Impurities Feiwen Mao New AFLATOXIN G1 PF 44(1) Pg. ONLINE Aflatoxin G1, Maria Monagas New AFLATOXIN B2 PF 44(1) Pg. ONLINE Aflatoxin B2, Maria Monagas New AFLATOXIN B1 PF 44(1) Pg. ONLINE Aflatoxin B1, Maria Monagas New AFLATOXIN G2 PF 44(1) Pg. ONLINE Aflatoxin G2, Maria Monagas Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Alcohol Content, PERFORMANCE TESTS/Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders-Performance Quality Tests <601>, C. Aerodynamic Size Distribution- Inhalation Aerosols, Sprays, and Powders, PERFORMANCE TESTS/Delivered-Dose Uniformity (Between Units), PERFORMANCE TESTS/Delivered-Dose Uniformity (Within Unit), IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Sulfate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol Determination-Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Albuterol Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards New ALBUTEROL INHALATION AEROSOL PF 44(1) Pg. ONLINE <11>/USP Levalbuterol Related Compound D RS Ravi Ravichandran ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Revision ALCLOMETASONE DIPROPIONATE CREAM PF 43(1) Pg. ONLINE Dipropionate RS Mary Koleck ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Revision ALCLOMETASONE DIPROPIONATE OINTMENT PF 43(1) Pg. ONLINE Dipropionate RS Mary Koleck Title, Chemical Info/Chemical Structure, Chemical Info/C17H18N4O·HCl, Chemical Info/330.82, Chemical Info/1H-Pyrido[4,3-b]indol-1-one, 2,3,4,5-tetrahydro-5-methyl- 2-[(5-methyl-1H-imidazol-4-yl)methyl]-, hydrochloride;, Chemical Info/2,3,4,5- Tetrahydro-5-methyl-2-[(5-methylimidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alosetron Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP New ALOSETRON HYDROCHLORIDE PF 43(2) Pg. ONLINE Alosetron Related Compound A RS Andrea Carney Title, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>,