化工级土霉h素质量标准.docVIP

General Notices (Ph Eur monograph 0199) C22H24N2O9, 2H2O496.479-57-2 Action and use Antibacterial. Preparation Oxytetracycline Tablets Ph Eur DEFINITION (4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide dihydrate. Substance produced by the growth of certain strains of Streptomyces rimosus or obtained by any other means. Content 95.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance Yellow, crystalline powder. Solubility Very slightly soluble in water. It dissolves in dilute acid and alkaline solutions. IDENTIFICATION A. Thin-layer chromatography (2.2.27). Test solutionDissolve 5 mg of the substance to be examined in methanol R and dilute to 10 ml with the same solvent. Reference solution (a)Dissolve 5 mg of oxytetracycline CRSin methanol R and dilute to 10 ml with the same solvent. Reference solution (b)Dissolve 5 mg of oxytetracycline CRS, 5 mg of tetracycline hydrochloride R and 5 mg of minocycline hydrochloride R in methanol R and dilute to 10 ml with the same solvent. PlateTLC octadecylsilyl silica gel F254plate R. Mobile phaseMix 20 volumes of acetonitrile R, 20 volumes of methanol R and 60 volumes of a 63 g/l solution of oxalic acid R previously adjusted to pH 2 with concentrated ammonia R. Application1 μl. DevelopmentOver 3/4 of the plate. DryingIn air. DetectionExamine in ultraviolet light at 254 nm. System suitabilityThe chromatogram obtained with reference solution (b) shows 3 clearly separated spots. ResultsThe principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a). B. To about 2 mg add 5 ml of sulphuric acid R. A deep red colour develops. Add the so