Revisions to USP 30 NF 25, Second Supplement
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1 Revisions to USP 30 NF 25, Second Supplement Published June 2007 General Chapters Monographs: A C D N O S T Z Monograph Monograph Section Scientific Liaison USP Reference standards <11> Dissolution, Procedure for a Pooled Sample <711> Uniformity of dosage units <905> for acetaminophen for chlorpheniramine maleate for dextromethorphan hydrobromide Chemical structure Chemical formula Molecular weight Chemical names CAS name
2 USP Reference standards A, B ph Water Organic volatile impurities Isomeric ration Content of sulfate ALBUTEROL SULFATE PF 32(5) Pg ALBUTEROL SULFATE PF 32(5) Pg Foreign kernel oils Cottonseed oil Sesame oil Mineral oil and foreign fatty oils Foreign oils Free fatty acids <401> Iodine value <401> Saponification value <401> Acid value <401> Peroxide value <401> Unsaponifiable matter <401> Fatty acid composition Sterol composition Residual solvents <467> CAS Number
3 AMINOSALICYLATE SODIUM TABLETS PF 32(5) Pg AMINOSALICYLIC ACID PF 32(5) Pg Limit of m-aminophenol Pharmacopeial Discussion Group Sign-Off Document Chemical Info Chemical Info USP Reference standards <11> Loss on ignition <733> Loss on ignition <733> Carbonate Carbonate Chloride <221> Chloride <221> Sulfate <221>
4 Sulfate <221> Arsenic, Method I <211> Barium Barium, Method I <231> APOMORPHINE HYDROCHLORIDE PF 32(5) Pg BENAZEPRIL HYDROCHLORIDE PF 32(5) Pg BENAZEPRIL HYDROCHLORIDE PF 32(5) Pg BENAZEPRIL HYDROCHLORIDE PF 32(5) Pg BISMUTH SUBSALICYLATE TABLETS PF 32(5) Pg BISMUTH SUBSALICYLATE TABLETS PF 32(5) Pg Limit of acid-insoluble substances Limit of acid-insoluble substances Limit of fluoride Organic volatile impurities, Method IV <467> Residual solvents <467> Absorptivity USP Reference standards <11> Microbial enumeration <2021>
5 , Method II <231> Content of triterpene glycosides Other requirements USP Reference standards <11> Botanic characteristics Microbial enumeration <2021> Loss on drying <731> Foreign organic matter <561> Total ash <561> Acid-insoluble ash <561> Alcohol-soluble extractives, Method 2 <561> Pesticide residues <561> <231> Content of triterpene glycosides USP Reference standards <11> Weight variation <2091> Disintegration <2040> Microbial enumeration <2021> BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS PF 32(4) Pg BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS PF 32(4) Pg Content of triterpene glycosides Drug release <724> Dissolution <711>
6 USP Reference standards A, B Osmolality ph BUTORPHANOL TARTRATE NASAL SOLUTION PF 32(4) Pg BUTORPHANOL TARTRATE NASAL SOLUTION PF 32(4) Pg BUTORPHANOL TARTRATE NASAL SOLUTION PF 32(4) Pg Delivered dose uniformity over the entire contents Microbial limits <61> Chemical Info USP Reference standards <11> Water, Method Ic <921> Specific rotation <781S> Residue on ignition <281>, Method II <231>
7 USP Reference standards <11> Dissolution <711> CARBOMER COPOLYMER PF 32(5) Pg CARBOMER COPOLYMER PF 32(5) Pg CARBOXYMETHYLCELLULOSE CALCIUM PF 31(5) Pg CARBOXYMETHYLCELLULOSE SODIUM 12 PF 31(5) Pg CARBOXYMETHYLCELLULOSE SODIUM 12 PF 31(5) Pg CARBOXYMETHYLCELLULOSE SODIUM 12 PF 31(5) Pg CARBOXYMETHYLCELLULOSE SODIUM PASTE PF 31(5) Pg CARBOXYMETHYLCELLULOSE SODIUM PF 31(5) Pg Uniformity of dosage units <905> Limit of ethyl acetate and cyclohexane Limit of benzene Viscosity Chemical Info USP Reference standards A, B ph Loss on drying Residue on ignition
8 Chemical structure Chemical formula Molecular weight Chemical names CAS number USP Reference standards A, B Loss on drying Residue on ignition Chloride CILOSTAZOL PF 32(5) Pg Chloride <221> CILOSTAZOL PF 32(5) Pg CIPROFLOXACIN INJECTION PF 32(4) Pg Bacterial endotoxins <85> CITALOPRAM HYDROBROMIDE PF 32(4) Pg CITALOPRAM HYDROBROMIDE PF 32(4) Pg USP Reference standards <11> CITALOPRAM HYDROBROMIDE PF 32(4) Pg A C -A COD LIVER OIL PF 32(5) Pg USP Reference standards
9 CORN SYRUP SOLIDS PF 28(6) Pg Residue on ignition Starch Total solids Limit of sulfur dioxide Limit of lead for reducing sugars (dextrose equivalent) Microbial limits General Chapters Monographs: A C D N O S T Z
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