双氯芬酸钠栓BP.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Diclofenac Sodium Diclofenac Sodium General Notices (Ph Eur monograph 1002) C H Cl NNaO 318.115307-79-6 14 10 2 2 Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. Preparations Prolonged-release Diclofenac Capsules Gastro-resistant Diclofenac Tablets Prolonged-release Diclofenac Tablets Ph Eur DEFINITION Sodium 2-[(2,6-dichlorophenyl)amino]phenyl]acetate. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or slightly yellowish, slightly hygroscopic, crystalline powder. Solubility Sparingly soluble in water, freely soluble in methanol, soluble in ethanol (96 per cent), slightly soluble in acetone. ©Crown Copyright 2006 1 mp: about 280 °C, with decomposition. IDENTIFICATION First identificationA, D. Second identificationB, C, D. A. Infrared absorption spectrophotometry (2.2.24). PreparationDiscs. Comparisondiclofenac sodium CRS. B. Thin-layer chromatography (2.2.27). Test solutionDissolve 25 mg of the substance to be examined in methanol R and dilute to 5 ml with the same solvent. Reference solution (a)Dissolve 25 mg of diclofenac sodium CRS in methanol R and dilute to 5 ml with the same solvent. Reference solution (b)Dissolve 10 mg of indometacin R in reference solution (a) and dilute to 2 ml with the same solution. PlateTLC silica gel GF plate R. 254 Mobile phaseconcentrated ammonia R, methanol R, ethyl acetate R (10:10:80 V/V/V). Application 5 µl. DevelopmentOver a path of 10 cm. DryingIn air. DetectionExamine in ultraviolet light at 254 nm. System suitabilityReference solution (b): — the chromatogram shows 2 clearly separated spots. ResultsThe princ