ABSTRACT
Procedures for quantitating the lactam impurity, 7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one 4-oxide, which can be present in chlordiazepoxide formulations, is presented. The method consists of trapping chlordiazepoxide in sulfuric acid in kieselguhr, eluting the impurity with ether, and quantitating by UV spectrophotometry in absolute alcohol at 312 nm.
Subject(s)
Chlordiazepoxide/analysis , Benzodiazepinones/analysis , Chromatography, Gel , Drug Contamination , Lactams/analysisABSTRACT
The commonly used 4-aminoantipyrine dye formation procedure for hexachlorophene analysis in topical formulations was modified to overcome interference due to other components. Bar soaps and nonemulsion formulations are analyzed directly, employing a chloroform back-extraction stage of the dye prior to quantitation. Hexachlorophene in emulsions and liquid soaps is determined using a TLC separation prior to dye formation.
Subject(s)
Hexachlorophene/analysis , Ammonia , Antipyrine/analogs & derivatives , Antipyrine/analysis , Buffers , Chromatography, Thin Layer/methods , Colorimetry/methods , Emulsions/analysis , Ferricyanides , Ointments/analysis , SolutionsSubject(s)
Trifluoperazine/analysis , Acids , Chromatography , Colorimetry , Coloring Agents , Methods , Pharmaceutic Aids , Spectrophotometry , Tablets , Ultraviolet RaysSubject(s)
Pharmaceutical Preparations/standards , Pharmacopoeias as Topic , Tablets/standards , Canada , Chemistry, Pharmaceutical , Europe , France , Pharmaceutical Preparations/analysis , Scandinavian and Nordic Countries , Tablets/analysis , USSR , United Kingdom , United States , World Health OrganizationABSTRACT
Pangamic acid is shown to be a mixture of variable composition. Criteria of identity and methods of analysis are described for five pharmaceutical dosage forms. Experimental results indicate that the products are not uniform in composition and that composition does not conform to label claims. No satisfactory preclinical drug application for any such preparation has so far been submitted to the Food and Drug Directorate.
