Antonio Hernandez-Cardoso <1239> VACCINES FOR HUMAN USE -- VIRAL VACCINES PF 41(5) Pg. ONLINE
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1 Compendial Cancellations for USP39-NF34 2S Category Monograph Title Monograph Section Scientific Liaison Revision <1> INJECTIONS PF 41(5) Pg. ONLINE INTRODUCTION Desmond Hunt New <1029> GOOD DOCUMENTATION GUIDELINES PF 40(3) Pg. ONLINE Title, INTRODUCTION, PRINCIPLES OF GOOD DOCUMENTATION, DATA COLLECTION AND RECORDING, DIFFERENT TYPES OF GMP DOCUMENTS Antonio Hernandez-Cardoso New <1239> VACCINES FOR HUMAN USE -- VIRAL VACCINES PF 41(5) Pg. ONLINE Title, 1. INTRODUCTION, 1.2 INACTIVATED VIRAL VACCINES, 1.3 SUBUNIT VACCINES, 1.4 VIRUS-LIKE PARTICLE VACCINES, 2. RAW MATERIALS, 3. EGGS AND PRIMARY CELL LINES USED IN VIRAL VACCINE PRODUCTION, 4. SEED LOT SYSTEMS AND CELL BANKS, 5. CULTURE AND HARVEST, 6. PURIFICATION, 7. VIRAL INACTIVATION, 8. INTERMEDIATES, 9. DRUG SUBSTANCE, 10. DRUG PRODUCT AND LOT RELEASE TESTS, 11. OTHER REQUIREMENTS Dibyendu Saha Revision ACETAMINOPHEN SUPPOSITORIES PF 39(3) Pg. ONLINE IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products <227> Clydewyn Anthony New ACETONITRILE, CHROMATOGRAPHIC PF 41(5) Pg. ONLINE Acetonitrile, Chromatographic Margareth Marques Revision AMILORIDE HYDROCHLORIDE PF 40(1) Pg. ONLINE IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amiloride Related Compound A RS Sujatha Ramakrishna New GAMMA-AMINOBUTYRIC ACID PF 41(3) Pg. ONLINE Title, Chemical Info/Chemical Structure, Chemical Info/C4H9NO2, Chemical Info/103.12, Chemical Info/4-Aminobutanoic acid, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Chloride and Sulfate <221>, Chloride, IMPURITIES/Chloride and Sulfate <221>, Sulfate, IMPURITIES/Related Compounds, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gamma- Aminobutyric Acid RS Revision AMITRAZ CONCENTRATE FOR DIP PF 41(2) Pg. ONLINE IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A. Infrared Absorption <197> Huy Dinh Morgan Puderbaugh
2 Revision METHYLENE BLUE INJECTION, VETERINARY PF 40(6) Pg. ONLINE {Title} Compounded, DEFINITION/Introduction, ADDITIONAL REQUIREMENTS/Beyond-Use Date Revision CALCIUM PANTOTHENATE PF 40(6) Pg. ONLINE IMPURITIES/Related Compounds Huy Dinh Revision CEFAZOLIN OPHTHALMIC SOLUTION PF 40(5) Pg. ONLINE {Title} Compounded, DEFINITION/Introduction, SPECIFIC TESTS/Sterility, ADDITIONAL REQUIREMENTS/Beyond-Use Date Revision COCAINE AND TETRACAINE HYDROCHLORIDES AND EPINEPHRINE TOPICAL SOLUTION PF 40(5) Pg. ONLINE {Title} Compounded, DEFINITION/Introduction, ADDITIONAL REQUIREMENTS/Beyond-Use Date New DEXMEDETOMIDINE INJECTION PF 40(6) Pg. ONLINE Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, ASSAY/Content of Sodium Chloride, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexmedetomidine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levomedetomidine RS New DEXTRAN OF WEIGHT-AVERAGE MOLECULAR WEIGHT 3,500,000 G/MOL PF 40(1) Pg. ONLINE Dextran, Weight-Average Molecular Weight 3,500,000 g/mol New DOXERCALCIFEROL CAPSULES PF 40(6) Pg. ONLINE Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Butylated Hydroxyanisole (if present), PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxercalciferol RS Sujatha Ramakrishna Hong Wang Elena Gonikberg
3 Revision DOXYCYCLINE FOR ORAL SUSPENSION PF 41(5) Pg. ONLINE IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197A>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxycycline Monohydrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxycycline Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methacycline Hydrochloride RS Morgan Puderbaugh New G##_Octreotide Acetate, PTA-5 PF 36(6) Pg G## (Octreotide Acetate, PTA-5) Trish Li Revision GLYCINE PF 40(3) Pg. ONLINE IMPURITIES/Related Compounds, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-isoleucine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-leucine RS Huy Dinh Revision HYDROXYZINE HYDROCHLORIDE PF 41(1) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4- Chlorobenzophenone RS 4-Chlorobenzophenone.C13H9ClO Heather Joyce Revision HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION PF 41(2) Pg. ONLINE IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4- Chlorobenzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Hydroxyzine Related Compound A RS Revision IBUPROFEN ORAL SUSPENSION PF 41(1) Pg. ONLINE IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzoic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ibuprofen Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ibuprofen Related Compound J RS Heather Joyce Hillary Cai
4 New INTERFERON BETA-1A PF 41(3) Pg. ONLINE Title, Chemical Info/Chemical Structure, Chemical Info/C908H1406N246O252S7, Chemical Info/approximately Da, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Bioidentity, IDENTIFICATION/B., IDENTIFICATION/C. Peptide Mapping, ASSAY/Procedure, IMPURITIES/Impurities with Molecular Masses Different from Those of Main Interferon beta-1a, IMPURITIES/Oxidized Interferon beta-1a, SPECIFIC TESTS/Analysis of N-Linked Oligosaccharides, SPECIFIC TESTS/Quantitation of Biantennary Sialylation, SPECIFIC TESTS/Osmolality and Osmolarity <785>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Interferon beta-1a RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Interferon beta-1a for Bioidentity RS New INTERFERON BETA-1A INJECTION PF 41(3) Pg. ONLINE Title, DEFINITION/Introduction, IDENTIFICATION/A. Bioidentity, IDENTIFICATION/B., IDENTIFICATION/C. Peptide Mapping, ASSAY/Procedure, IMPURITIES/Impurities with Molecular Masses Different from Those of Main Interferon beta-1a, IMPURITIES/Oxidized Interferon beta-1a, SPECIFIC TESTS/Analysis of N-Linked Oligosaccharides, SPECIFIC TESTS/Quantitation of Biantennary Sialylation, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Osmolality and Osmolarity <785>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Subvisible Particulate Matter in Therapeutic Protein Injections <787>, SPECIFIC TESTS/Injections and Implanted Drug Products <1>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Interferon beta-1a RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Interferon beta-1a for Bioidentity RS Maura Kibbey Maura Kibbey
5 New L##_Polyethylene Glycol 3350, Aquagel OH 40 PF 40(1) Pg. ONLINE L## (Polyethylene Glycol 3350, Aquagel-OH40) Hong Wang Revision MENTHOL IMPURITIES/Related Compounds Nam-Cheol Kim New METHANOL, CHROMATOGRAPHIC PF 41(5) Pg. ONLINE Methanol, Chromatographic Margareth Marques Revision METHIONINE PF 41(1) Pg. ONLINE IMPURITIES/Related Compounds, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-serine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP N-Acetyl-d,l-methionine RS Huy Dinh Revision METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS PF 41(3) Pg. ONLINE IDENTIFICATION/C., PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metoprolol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metoprolol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Metoprolol Related Compound C RS Revision MICONAZOLE NITRATE PF 41(4) Pg. ONLINE IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Miconazole Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Miconazole Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Miconazole Related Compound I RS Revision OMEPRAZOLE ORAL SUSPENSION PF 40(6) Pg. ONLINE {Title} and Sodium Bicarbonate Compounded, DEFINITION/Introduction, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date Revision PANTOPRAZOLE ORAL SUSPENSION PF 40(6) Pg. ONLINE {Title} Sodium Compounded, DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date Donald Min Clydewyn Anthony
6 Revision PHENOL PF 41(5) Pg. ONLINE DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, SPECIFIC TESTS/Clarity of Solution and Reaction, SPECIFIC TESTS/Congealing Temperature <651>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> New POLYETHYlene GLYCOL STANDARDS WITH MOLECULAR WEIGHTS OF 960, 1960, 3020, 6430, AND 12,300 DALTONS (G/MOL) PF 40(1) Pg. ONLINE Polyethylene Glycol Standards with Molecular Weights of 960, 1960, 3020, 6430, and 12,300 Daltons (g/mol) Alan Potts Hong Wang Revision SODIUM NITROPRUSSIDE PF 41(4) Pg. ONLINE IDENTIFICATION/Identification Tests-General <191>, Sodium Donald Min Revision SILVER SULFADIAZINE PF 41(4) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfanilamide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sulfanilic Acid RS Revision SULFISOXAZOLE PF 41(5) Pg. ONLINE DEFINITION/Introduction, IDENTIFICATION/C. Procedure, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Revision SULFISOXAZOLE ACETYL PF 41(5) Pg. ONLINE DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741> Praveen Pabba Praveen Pabba Praveen Pabba
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