Compendial Approvals for USP42-NF37 1S

1 Compendial Approvals for USP42-NF37 1 SCategoryMonograph TitleMonograph SectionScientific LiaisonRevision<2> ORAL DRUG PRODUCTS-PRODUCT QUALITY TESTS PF 44(2) Pg. ONLINEPRODUCT QUALITY TESTS FOR ORAL DRUG PRODUCTSA ntonio Hernandez-CardosoRevisionDESCRIPTION AND SOLUBILITY PF 43(5) Pg. ONLINED esvenlafaxine, Desvenlafaxine Fumarate, Desvenlafaxine Succinate, Benzphetamine Hydrochloride, Dichlorphenamide, Nilotinib, FluorometholoneHeather JoyceRevision<41> BALANCES PF 44(2) Pg. ONLINEREPEATABILITYW illiam BrownRevision<64> PROBIOTIC TESTS PF 44(3) Pg. ONLINEINTRODUCTION/, IDENTIFICATION/Introduction, IDENTIFICATION/Identification for Non-Spore-Forming Bacterial Strains, Introduction, Enumeration for Non-Spore-Forming Bacteria Strains, PERFORMANCE TESTS/Introduction, PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Disintegration, PERFORMANCE TESTS/Weight Variation <2091>, CONTAMINANTS/Introduction, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/LabelingMaria MonagasNew<644> CONDUCTIVITY OF SOLUTIONS Stage 6 HarmonizationEntire DocumentAntonio Hernandez-CardosoRevision<701> DISINTEGRATION PF 44(2) Pg.

2 ONLINEI ntroduction, PROCEDURE AND CRITERIAW illiam BrownRevision<729> GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS PF 44(2) Pg. ONLINEMETHOD I-LIGHT-SCATTERING METHOD, METHOD II-MEASUREMENT OF LARGE GLOBULE CONTENT BY LIGHT OBSCURATION OR EXTINCTION METHODD esmond HuntRevision<1057> BIOTECHNOLOGY-DERIVED ARTICLES -- TOTAL PROTEIN ASSAY PF 44(1) Pg. ONLINEI ntroduction, INTRODUCTION, SAMPLE EXTRACTION METHODS FOR TOTAL PROTEIN ASSAYS, TOTAL PROTEIN MEASUREMENT PROCEDURESE lena CurtiRevision<1151> PHARMACEUTICAL DOSAGE FORMS PF 44(3) Pg. ONLINEGENERAL CONSIDERATIONS, DOSAGE FORMS, GLOSSARYW illiam BrownRevisionACETAZOLAMIDE PF 43(4) Pg. ONLINEIMPURITIES/Silver-Reducing Substances, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic ImpuritiesFeiwen MaoNew2-ACETYLRESORCINOL PF 44(3) Pg.

3 ONLINE2-AcetylresorcinolMargareth MarquesRevisionAMANTADINE HYDROCHLORIDE PF 43(4) Pg. ONLINEDEFINITION/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 RSShankari ShivaprasadRevisionAMANTADINE HYDROCHLORIDE CAPSULES PF 43(4) Pg. Absorption <197S> <197>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/Shankari ShivaprasadRevisionAMANTADINE HYDROCHLORIDE ORAL SOLUTION PF 43(4) Pg.

4 ONLINEIDENTIFICATION/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 RSShankari ShivaprasadRevisionAMCINONIDE PF 44(3) Pg. ONLINEIDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Butylparaben RSMary KoleckRevisionAMCINONIDE OINTMENT PF 44(3) Pg. ONLINEIDENTIFICATION/Thin-Layer Chromatography, ASSAY/Procedure, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Butylparaben RSMary KoleckRevisionAMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS PF 44(3) Pg.

5 ONLINEIDENTIFICATION/Thin-Layer Chromatography, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and StorageEdith ChangOmissionAMINOBENZOATE POTASSIUM FOR ORAL SOLUTION PF 44(3) Pg. ONLINEE ntire documentWei YangOmissionAMINOGLUTETHIMIDE PF 44(2) Pg. ONLINEE ntire documentHeather JoyceOmissionAMINOGLUTETHIMIDE TABLETS PF 44(2) Pg. ONLINEE ntire documentHeather JoyceOmissionAMINOSALICYLATE SODIUM PF 44(2) Pg. ONLINEE ntire documentShankari ShivaprasadOmissionAMINOSALICYLATE SODIUM TABLETS PF 44(2) Pg. ONLINEE ntire documentShankari ShivaprasadOmissionAMINOSALICYLIC ACID TABLETS PF 44(2) Pg.

6 ONLINEE ntire documentRamanujam N Ammonium Thiocyanate VS PF 44(3) Pg. N Ammonium Thiocyanate VSMargareth MarquesRevisionASTAXANTHIN ESTERS PF 44(3) Pg. ONLINEASSAY/Content of Total Astaxanthin, CONTAMINANTS/Limit of Benzo[a]pyrene (BaP), Benzo[b]fluoranthene (BbF), Benzo[a]anthracene (BaA), and Chrysene (CHR)Huy DinhNewAZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION PF 43(3) Pg. ONLINET itle, 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 RSMary KoleckRevisionAZITHROMYCIN FOR INJECTION PF 44(2) Pg.

7 ONLINEIDENTIFICATION/B. Infrared Absorption <197A>, IMPURITIES/Limit of Azithromycin N-Oxide, Desosaminylazithromycin, and N-Demethylazithromycin, IMPURITIES/Limit of Aminoazithromycin, Formamido Analog, Methylformamido Analog, and 3 -De(dimethylamino)-3 -oxoazithromycin (if present), SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>Praveen PabbaRevisionBENAZEPRIL HYDROCHLORIDE TABLETS PF 44(2) Pg. ONLINEIDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., 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 Benazepril Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benazepril Related Compound C RSEdith ChangNewBENZPHETAMINE HYDROCHLORIDE PF 43(3) Pg.

8 ONLINEC hemical Info/Chemical Structure, Chemical Info/C17H21N HCl, Chemical , Chemical Info/(+)-N-Benzyl-N, -dimethylphenethylamine hydrochloride;, Chemical Info/(S)-N-Benzyl-N-methyl-1-phenylpropa n-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.

9 ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzphetamine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzyl Chloride RSWei YangNewBENZPHETAMINE HYDROCHLORIDE TABLETS PF 43(3) Pg. ONLINEDEFINITION/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 RSWei YangOmissionCEFAZOLIN OPHTHALMIC SOLUTION PF 44(3) Pg.

10 ONLINEE ntire documentJeanne SunRevisionCHLORHEXIDINE GLUCONATE TOPICAL GEL PF 43(6) Pg. ONLINEIDENTIFICATION/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 RSSujatha RamakrishnaRevisionCHOLECALCIFEROL CAPSULES PF 44(2) Pg. ONLINEASSAY/Procedure, ADDITIONAL REQUIREMENTS/LabelingNatalia DavydovaNewCLINDAMYCIN HYDROCHLORIDE COMPOUNDED ORAL SOLUTION PF 44(2) Pg. ONLINEDEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clindamycin Hydrochloride RSBrian SerumagaRevisionCLINDAMYCIN HYDROCHLORIDE ORAL SOLUTION PF 44(2) Pg.