盐酸氟西汀BP2009质量标准.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Fluoxetine Hydrochloride Fluoxetine Hydrochloride General Notices (Ph Eur monograph 1104) C H F NO,HCl345.859333-67-4 17 18 3 Action and use Selective serotonin reuptake inhibitor; antidepressant. Preparations Fluoxetine Capsules Fluoxetine Oral Solution Ph Eur DEFINITION (3RS)-N-Methyl-3-phenyl-3-[4-trifluoromethyl)phenoxy]propan-1-amine hydrochloride. Content 98.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water, freely soluble in methanol, sparingly soluble in methylene chloride. IDENTIFICATION A. Infrared absorption spectrophotometer (2.2.24). PreparationDiscs. ©Crown Copyright 2006 1 Comparisonfluoxetine hydrochloride CRS . B. It gives reaction (a) of chlorides (2.3.1). TESTS Solution S Dissolve 2.0 g in a mixture of 15 volumes of water R and 85 volumes of methanol R, then dilute to 100 ml with the same mixture of solvents. Appearance of solution Solution S is clear (2.2.1) and colourless (2.2.2, Method II). pH (2.2.3) 4.5 to 6.5. Dissolve 0.20 g in carbon dioxide-free water R and dilute to 20 ml with the same solvent. Optical rotation (2.2.7) - 0.05 ° to + 0.05 °, determined on solution S. Related substances Liquid chromatography (2.2.29). Test solution (a)Dissolve 55.0 mg of the substance to be examined in the mobile phase and dilute to 10.0 ml with the mobile phase. Test solution (b)Dilute 2.0 ml of test solution (a) to 10.0 ml with the mobile phase. Reference solutionDissolve 22.0 mg of fluoxetine hydrochloride CRS in 10.0 ml of 0.5 M sulphuric acid . Heat at about 85 °C for 3 h. Allow to cool. The resulting solution contains considerable quan