氟他胺BP2010药典标准.docVIP

British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Flutamide 商丘嘉美化工有限公司 General Notices(Ph Eur monograph 1423) C11H11F3N2O3????276.2????13311-84-7 Action and use Antiandrogen. Ph Eur DEFINITION 2-Methyl-N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide. Content 97.0 per cent to 103.0 per cent (dried substance). CHARACTERS Appearance Pale yellow, crystalline powder. Solubility Practically insoluble in water, freely soluble in acetone and in ethanol (96 per cent). mp: about 112 °C. IDENTIFICATION Infrared absorption spectrophotometry (2.2.24). Comparison??flutamide CRS. TESTS Related substances Liquid chromatography (2.2.29). Test solution??Dissolve 20.0 mg of the substance to be examined in the mobile phase and dilute to 20.0 ml with the mobile phase. Reference solution (a)??Dissolve 2 mg of flutamide CRS and 2 mg of flutamide impurity C CRS in the mobile phase, then dilute to 50.0 ml with the mobile phase. Dilute 1.0 ml of this solution to 20.0 ml with the mobile phase. Reference solution (b)??Dilute 1.0 ml of the test solution to 50.0 ml with the mobile phase. Dilute 2.0 ml of this solution to 20.0 ml with the mobile phase. Column: — size: l??=??0.25 m, ???=??4.0 mm; — stationary phase: octadecylsilyl silica gel for chromatography R (5 μm). Mobile phase??acetonitrile R, water R (50:50 V/V). Flow rate??0.5 ml/min. Detection??Spectrophotometer at 240 nm. Injection??20 μl. Run time??1.5 times the retention time of flutamide. Retention time??Impurity C??=??about 14 min; flutamide??=??about 19 min. Relative retention??With reference to flutamide: impurity C??=??about 0.72. System suitability??Reference solution (a): — resolution: minimum 10.5 between the peaks due to impurity C and flutamide. Limits: — impurity C: not more than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent); — impurities A, B, D, E, F: for each impurity, not more than the area of the princi