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Revisions to USP32–NF27, Second Supplement

Published April 2009

General Chapters  
Monographs: A–C   D–N   O–S   T–Z  


Monograph Title Monograph Section Scientific Liaison
DANTROLENE SODIUM CAPSULES PF 34(5) Pg. 1151 Packaging and storage Ravi Ravichandran
DESMOPRESSIN ACETATE NASAL SPRAY PF 31(4) Pg. 1059 Title, Definition, Packaging and storage, Labeling, USP Reference standards, Identification, pH, Uniformity of unit spray weight and total number of discharges per container, Assay, Microbial limits Thomas Sigambris
DEXTROAMPHETAMINE SULFATE PF 34(4) Pg. 921 Definition, USP Reference standards <11>, Identification, Chromatographic purity, Related compounds, Organic volatile impurities, Method I <467>, Assay Ravi Ravichandran
DICYCLOMINE HYDROCHLORIDE PF 34(5) Pg. 1152 Readily carbonizable substances <271> Elena Gonikberg
DOPAMINE HYDROCHLORIDE PF 34(5) Pg. 1152 Readily carbonizable substances <271> Sujatha Ramakrishna
DOXAZOSIN MESYLATE PF 34(5) Pg. 1152 Assay Sujatha Ramakrishna
ECAMSULE SOLUTION PF 34(5) Pg. 1153 Title, Chemical Info, Definition, Packaging and storage, USP Reference standards <11>, Labeling, Identification, Limit of chloride, Limit of sodium, Related compounds, Assay Feiwen Mao
ENROFLOXACIN PF 34(4) Pg. 924 Title, Chemical Info, Definition, Packaging and storage, Labeling, USP Reference standards <11>, Clarity of solution, Color of solution, Identification, Loss on drying <731>, Residue on ignition <281>, Chloride <221>, Sulfate <221>, Heavy metals Method II <231>, Limit of N-ethylpiperazine, Related compounds, Assay Elena Gonikberg
ERYTHROMYCIN PLEDGETS PF 34(5) Pg. 1157 Identification, Other requirements Ahalya Wise
STERILE ERYTHROMYCIN ETHYLSUCCINATE PF 34(5) Pg. 1158 Identification, Other requirements Ahalya Wise
ETHYL ACETATE PF 34(5) Pg. 1223 Readily carbonizable substances <271> Robert Lafaver
ETHYL MALTOL PF 34(5) Pg. 1224 Title, Chemical Info, Definition, Packaging and storage, USP Reference standards <11>, Identification, Residue on ignition <281>, Water, Method I <921>, Assay Robert Lafaver
FAMOTIDINE FOR ORAL SUSPENSION PF 34(5) Pg. 1158 Uniformity of dosage units <905> Elena Gonikberg
FEXOFENADINE HYDROCHLORIDE TABLETS PF 34(4) Pg. 931 Dissolution <711> Margareth Marques
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS PF 34(5) Pg. 1158 Labeling, USP Reference standards <11>, Related compounds, Assay Domenick Vicchio
FISH OIL CONTAINING OMEGA-3 ACIDS PF 34(5) Pg. 1207 Content of EPA and DHA Curtis Phinney
FLUCONAZOLE TABLETS PF 34(4) Pg. 932 Title, Definition, Packaging and storage, USP Reference standards <11>, Identification, Dissolution <711>, Uniformity of dosage units <905>, Assay Behnam Davani
FLUDARABINE PHOSPHATE FOR INJECTION PF 34(4) Pg. 933 Related compounds Feiwen Mao
GABAPENTIN TABLETS PF 34(4) Pg. 934 Labeling, Dissolution <711> Margareth Marques
GLIMEPIRIDE TABLETS PF 33(3) Pg. 411 Dissolution <711> Margareth Marques
GLUTAMIC ACID PF 34(4) Pg. 997 Title, Chemical Info, Definition, Packaging and storage, USP Reference standards <11>, Identification, Specific rotation <781S>, Loss on drying <731>, Residue on ignition <281>, Chloride <221>, Sulfate <221>, Iron <241>, Heavy metals, Method I <231>, Chromatographic purity, Assay Curtis Phinney
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS PF 34(5) Pg. 1163 Identification Elena Gonikberg
GRANISETRON HYDROCHLORIDE TABLETS PF 34(4) Pg. 937 Title, Definition, Packaging and storage, USP Reference standards <11>, Identification, Dissolution <711>, Uniformity of dosage units <905>, Related compounds, Assay Elena Gonikberg
GRANISETRON HYDROCHLORIDE INJECTION PF 34(4) Pg. 935 Title, Definition, Packaging and storage, Labeling, USP Reference standards <11>, Identification, Bacterial endotoxins <85>, Sterility <71>, pH <791>, Particulate matter <788>, Related compounds, Other requirements, Assay Elena Gonikberg
GROUND LIMESTONE PF 34(4) Pg. 998 Title, Definition, Packaging and storage, USP Reference standards <11>, Identification, Loss on drying <731>, Acid-insoluble substances, Limit of fluoride, Arsenic, Method I <211>, Lead <251>, Limit of magnesium and alkali salts, Heavy metals <231>, Assay Curtis Phinney
GUGGUL PF 34(4) Pg. 1000 Title, Definition, Packaging and storage, Labeling, Botanic characteristics, USP Reference standards <11>, Identification, Foreign organic matter <561>, Residue on ignition <281>, Acid-insoluble ash <561>, Loss on drying <731>, Heavy metals, Method III <231>, Pesticides residue <561>, Alcohol-soluble extractives, Method 2 <561>, Ethyl acetate soluble extractives, Content of guggulsterones E and Z Maged Sharaf
NATIVE GUGGUL EXTRACT PF 34(4) Pg. 1002 Title, Definition, Packaging and storage, Labeling, USP Reference standards <11>, Identification, Microbial enumeration <2021>, Absence of specified microorganisms <2022>, Water, Method Ia <921>, Heavy metals, Method II <231>, Pesticides residue <561>, Content of guggulsterones E and Z, Other requirements Maged Sharaf
PURIFIED GUGGUL EXTRACT PF 34(4) Pg. 1003 Title, Definition, Packaging and storage, Labeling, USP Reference standards <11>, Identification, Microbial enumeration <2021>, Absence of specified microorganisms <2022>, Heavy metals, Method II <231>, Pesticides residue <561>, Content of guggulsterones E and Z, Other requirements Maged Sharaf
GUGGUL TABLETS PF 34(4) Pg. 1004 Title, Definition, Packaging and storage, Labeling, USP Reference standards <11>, Identification, Microbial enumeration <2021>, Absence of specified microorganisms <2022>, Disintegration and dissolution <2040>, Weight variation <2091>, Residual solvents <467>, Content of guggulsterones E and Z Maged Sharaf
HYDROXYCHLOROQUINE SULFATE TABLETS PF 34(4) Pg. 940 Identification Behnam Davani
IBUPROFEN PF 34(4) Pg. 941 Chromatographic purity Clydewyn Anthony
IBUPROFEN TABLETS PF 34(4) Pg. 941 Limit of ibuprofen related compound C Clydewyn Anthony
IMIPRAMINE HYDROCHLORIDE PF 34(5) Pg. 1164 Melting range <741> Ravi Ravichandran
HUMAN INSULIN ISOPHANE SUSPENSION AND HUMAN INSULIN INJECTION PF 34(4) Pg. 941 Soluble insulin human content Thomas Sigambris
IRBESARTAN PF 34(5) Pg. 1164 Limit of azide Sujatha Ramakrishna
ITRACONAZOLE PF 34(4) Pg. 947 Title, Chemical Info, Definition, Packaging and storage, USP Reference standards <11>, Identification, Angular rotation <781A>, Melting range <741>, Loss on drying <731>, Residue on ignition <281>, Related compounds, Assay Behnam Davani
IVERMECTIN TABLETS PF 34(4) Pg. 948 Dissolution <711> Margareth Marques
LACTIC ACID PF 34(5) Pg. 1164 Readily carbonizable substances Curtis Phinney
LANOLIN ALCOHOLS PF 34(4) Pg. 1014 Chemical Info, Packaging and storage, Labeling, Acid value <401>, Hydroxyl value <401>, Peroxide value <401> Hong Wang
LAUROYL MACROGOLGLYCERIDES PF 34(5) Pg. 1224 Definition, Labeling, Identification, Hydroxyl value <401>, Saponification value <401>, Fatty acid composition <401>, Water, Method I <921>, Total ash <561>, Heavy metals, Method II <231>, Alkaline impurities Hong Wang
LEVALBUTEROL INHALATION SOLUTION PF 33(1) Pg. 79 Sterility <71> Radhakrishna Tirumalai
LEVOTHYROXINE SODIUM ORAL POWDER PF 34(4) Pg. 954 Identification Elena Gonikberg
LEVOTHYROXINE SODIUM TABLETS PF 34(4) Pg. 954 Identification Elena Gonikberg
LINDANE PF 34(2) Pg. 280 Assay Behnam Davani
LINOLEOYL MACROGOLGLYCERIDES PF 34(4) Pg. 1015 Definition, Labeling, Identification, Fatty acid composition <401>, Refractive index <831>, Water, Method I <921>, Total ash <561>, Heavy metals, Method II <231>, Alkaline impurities Hong Wang
LIOTHYRONINE SODIUM TABLETS PF 34(4) Pg. 955 Identification Elena Gonikberg
LIOTRIX TABLETS PF 34(4) Pg. 955 Identification Elena Gonikberg
ALPHA LIPOIC ACID PF 34(5) Pg. 1209 Limit of 6,8-epitrithiooctanoic acid, Limit of polymer content, Chromatographic purity, Assay Curtis Phinney
LISINOPRIL TABLETS PF 34(4) Pg. 956 Dissolution <711> Margareth Marques
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS PF 34(4) Pg. 956 Labeling, Dissolution <711> Margareth Marques
LOSARTAN POTASSIUM TABLETS PF 34(5) Pg. 1164 Title, Definition, Packaging and storage, USP Reference standards <11>, Identification, Dissolution <711>, Uniformity of dosage units <905>, Related compounds, Assay Sujatha Ramakrishna
MESNA PF 34(5) Pg. 1168 Title, Chemical Info, Definition, Packaging and storage, USP Reference standards <11>, Identification, pH <791>, Loss on drying, Limit of chloride, Heavy metals, Method I <231>, Assay Clydewyn Anthony
METHYL ALCOHOL PF 34(5) Pg. 1226 Readily carbonizable substances <271> Robert Lafaver
MIDAZOLAM PF 34(4) Pg. 961 Title, Chemical Info, Definition, Packaging and storage, USP Reference standards <11>, Identification, Loss on drying <731>, Residue on ignition <281>, Chromatographic purity, Assay Mary Waddell
MIDAZOLAM INJECTION PF 34(3) Pg. 635 Title, Definition, Packaging and storage, Labeling, USP Reference standards <11>, Identification, Bacterial endotoxins <85>, pH <791>, Benzyl alcohol content (if present), Particulate matter <788>, Other requirements, Related compounds, Assay Mary Waddell
MINOCYCLINE PERIODONTAL SYSTEM PF 34(4) Pg. 963 Title, Definition, Packaging and storage, USP Reference standards <11>, Identification, Microbial limits <61>, Drug release <724>, Uniformity of dosage units <905>, Water, Method I <921>, Related compounds, Assay Ahalya Wise
MIRTAZAPINE PF 34(4) Pg. 964 USP Reference standards <11>, Water, Method I <921>, Chromatographic purity-Related compounds, Assay Ravi Ravichandran
MOXIFLOXACIN HYDROCHLORIDE PF 34(5) Pg. 1170 Title, Chemical Info, Definition, Packaging and storage, USP Reference standards <11>, Identification, Specific rotation <781S>, Microbial limits <61>, pH <791>, Water, Method Ia <921>, Residue on ignition <281>, Sulfate <221>, Related compounds, Assay Behnam Davani
MOXIFLOXACIN OPHTHALMIC SOLUTION PF 34(5) Pg. 1173 Title, Definition, Packaging and storage, USP Reference standards <11>, Identification, Sterility <71>, pH <791>, Osmolality <785>, Related compounds, Assay Behnam Davani
MUPIROCIN NASAL OINTMENT PF 34(4) Pg. 966 Title, Definition, Packaging and storage, USP Reference standards <11>, Identification, Microbial limits <61>, Minimum fill <755>, Uniformity of dosage units <905>, Related compounds, Assay Ahalya Wise
NIACINAMIDE PF 34(5) Pg. 1176 Readily carbonizable substances <271> Curtis Phinney
NORETHINDRONE ACETATE PF 34(4) Pg. 969 Chromatographic purity Mary Waddell

General Chapters  
Monographs: A–C   D–N   O–S   T–Z