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Deferrals for USP42-NF37

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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>,
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    vr_meds_ex01_3b_0825s Coding Manual Supplement MEDNAME OTHER_CODE ATC_CODE SYSTEM THER_GP PHRM_GP CHEM_GP SODIUM FLUORIDE A12CD01 A01AA01 A A01 A01A A01AA SODIUM MONOFLUOROPHOSPHATE A12CD02 A01AA02 A A01 A01A A01AA HYDROGEN PEROXIDE D08AX01 A01AB02 A A01 A01A A01AB HYDROGEN PEROXIDE S02AA06 A01AB02 A A01 A01A A01AB CHLORHEXIDINE B05CA02 A01AB03 A A01 A01A A01AB CHLORHEXIDINE D08AC02 A01AB03 A A01 A01A A01AB CHLORHEXIDINE D09AA12 A01AB03 A A01 A01A A01AB CHLORHEXIDINE R02AA05 A01AB03 A A01 A01A A01AB CHLORHEXIDINE S01AX09 A01AB03 A A01 A01A A01AB CHLORHEXIDINE S02AA09 A01AB03 A A01 A01A A01AB CHLORHEXIDINE S03AA04 A01AB03 A A01 A01A A01AB AMPHOTERICIN B A07AA07 A01AB04 A A01 A01A A01AB AMPHOTERICIN B G01AA03 A01AB04 A A01 A01A A01AB AMPHOTERICIN B J02AA01 A01AB04 A A01 A01A A01AB POLYNOXYLIN D01AE05 A01AB05 A A01 A01A A01AB OXYQUINOLINE D08AH03 A01AB07 A A01 A01A A01AB OXYQUINOLINE G01AC30 A01AB07 A A01 A01A A01AB OXYQUINOLINE R02AA14 A01AB07 A A01 A01A A01AB NEOMYCIN A07AA01 A01AB08 A A01 A01A A01AB NEOMYCIN B05CA09 A01AB08 A A01 A01A A01AB NEOMYCIN D06AX04 A01AB08 A A01 A01A A01AB NEOMYCIN J01GB05 A01AB08 A A01 A01A A01AB NEOMYCIN R02AB01 A01AB08 A A01 A01A A01AB NEOMYCIN S01AA03 A01AB08 A A01 A01A A01AB NEOMYCIN S02AA07 A01AB08 A A01 A01A A01AB NEOMYCIN S03AA01 A01AB08 A A01 A01A A01AB MICONAZOLE A07AC01 A01AB09 A A01 A01A A01AB MICONAZOLE D01AC02 A01AB09 A A01 A01A A01AB MICONAZOLE G01AF04 A01AB09 A A01 A01A A01AB MICONAZOLE J02AB01 A01AB09 A A01 A01A A01AB MICONAZOLE S02AA13 A01AB09 A A01 A01A A01AB NATAMYCIN A07AA03 A01AB10 A A01
  • Alphabetical Listing of ATC Drugs & Codes

    Alphabetical Listing of ATC Drugs & Codes

    Alphabetical Listing of ATC drugs & codes. Introduction This file is an alphabetical listing of ATC codes as supplied to us in November 1999. It is supplied free as a service to those who care about good medicine use by mSupply support. To get an overview of the ATC system, use the “ATC categories.pdf” document also alvailable from www.msupply.org.nz Thanks to the WHO collaborating centre for Drug Statistics & Methodology, Norway, for supplying the raw data. I have intentionally supplied these files as PDFs so that they are not quite so easily manipulated and redistributed. I am told there is no copyright on the files, but it still seems polite to ask before using other people’s work, so please contact <[email protected]> for permission before asking us for text files. mSupply support also distributes mSupply software for inventory control, which has an inbuilt system for reporting on medicine usage using the ATC system You can download a full working version from www.msupply.org.nz Craig Drown, mSupply Support <[email protected]> April 2000 A (2-benzhydryloxyethyl)diethyl-methylammonium iodide A03AB16 0.3 g O 2-(4-chlorphenoxy)-ethanol D01AE06 4-dimethylaminophenol V03AB27 Abciximab B01AC13 25 mg P Absorbable gelatin sponge B02BC01 Acadesine C01EB13 Acamprosate V03AA03 2 g O Acarbose A10BF01 0.3 g O Acebutolol C07AB04 0.4 g O,P Acebutolol and thiazides C07BB04 Aceclidine S01EB08 Aceclidine, combinations S01EB58 Aceclofenac M01AB16 0.2 g O Acefylline piperazine R03DA09 Acemetacin M01AB11 Acenocoumarol B01AA07 5 mg O Acepromazine N05AA04
  • Method for the Enzymatic Kinetic Resolution of Acyloxyalkyl Thiocarbonates Used for the Synthesis of Acyloxyalkyl Carbamates

    Method for the Enzymatic Kinetic Resolution of Acyloxyalkyl Thiocarbonates Used for the Synthesis of Acyloxyalkyl Carbamates

    (19) TZZ Z_¥_T (11) EP 2 250 143 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: C07B 57/00 (2006.01) C07C 269/04 (2006.01) 20.04.2016 Bulletin 2016/16 C07C 329/06 (2006.01) C07D 207/46 (2006.01) C12P 41/00 (2006.01) C07C 271/22 (2006.01) (2006.01) (2006.01) (21) Application number: 09704177.6 A61K 31/325 C12P 11/00 (22) Date of filing: 23.01.2009 (86) International application number: PCT/US2009/031873 (87) International publication number: WO 2009/094569 (30.07.2009 Gazette 2009/31) (54) METHOD FOR THE ENZYMATIC KINETIC RESOLUTION OF ACYLOXYALKYL THIOCARBONATES USED FOR THE SYNTHESIS OF ACYLOXYALKYL CARBAMATES VERFAHREN ZUR ENZYMATISCHEN KINETISCHEN RACEMATSPALTUNG VON FÜR DIE SYNTHESE VON ACYLOXYALKYLCARBAMATEN VERWENDETEN ACYLOXYALKYLTHIOCARBONATEN RESOLUTION CINETIQUE ENZYMATIQUE DE THIOCARBONATES D’ACYLOXYALKYLE UTILISES DANS LA SYNTHESE DE CARBAMATES D’ACYLOXYALKYLE (84) Designated Contracting States: • PENG, Ge AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Mountain View HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL California 94040 (US) PT RO SE SI SK TR • RAILLARD, Stephen, P. Mountain View, California 94040 (US) (30) Priority: 25.01.2008 US 23813 P 25.01.2008 US 23808 P (74) Representative: Wytenburg, Wilhelmus Johannes 11.12.2008 US 121859 P et al Mewburn Ellis LLP (43) Date of publication of application: City Tower 17.11.2010 Bulletin 2010/46 40 Basinghall Street London EC2V 5DE (GB) (73) Proprietor: XenoPort, Inc.