马来酸氯苯那敏BP2015翻译.docx

ChlorphenamineMaleate马来酸氯苯那敏General Notices总体概述(Ph. Eur. monograph 0386)C20H23ClN2O4 390.9 113-92-8Action and use使用及用途Histamine H1 receptor antagonist; antihistamine.组胺H1受体拮抗剂；抗组胺药。Preparations制剂Chlorphenamine Injection马来酸氯苯那敏注射液Chlorphenamine Oral Solution马来酸氯苯那敏口服溶液Chlorphenamine Tablets马来酸氯苯那敏片Ph EurDEFINITION定义(3RS)-3-(4-Chlorophenyl)-N,N-dimethyl-3-(pyridin-2-yl)propan-1-amine hydrogen (Z)-butenedioate.（3RS）-3-（4-氯苯基）-N，N-二甲基-3 -（2-吡啶基）丙烷-1-胺氢（Z）—butenedioate。Content含量98.0 per cent to 101.0 per cent (dried substance).98.0~101.0%（按干燥品计算）CHARACTERS性状Appearance外观White or almost white, crystalline powder.白色或类白色结晶性粉末Solubility溶解度Freely soluble in water, soluble in ethanol (96 per cent).易溶于水，溶于乙醇（96.0%）IDENTIFICATION鉴别A. Melting point (2.2.14): 130 °C to 135 °C.熔点（2.2.14）130℃-135℃B. Infrared absorption spectrophotometry (2.2.24).Comparison chlorphenaminemaleate CRS.红外光吸收光谱（2.2.24）与马来酸氯苯那敏的对照品一致C. Optical rotation (see Tests).旋光度（见测试）TESTS测试Solution S溶液澄清度与颜色（溶液S）Dissolve 2.0 g in water R and dilute to 20.0 mL with the same solvent.取供试品2.0g，置于20ml容量瓶中，用水溶解并稀释至刻度。Appearance of solution溶液外观Solution S is clear (2.2.1) and not more intensely coloured than reference solution BY6(2.2.2, Method II).溶液S应澄清无色；如显色，与BY6比较不得更深。Optical rotation (2.2.7)旋光度-0.10° to + 0.10°, determined on solution S.-0.10°-+0.10°，用溶液S测定Related substances有关物质Liquid chromatography (2.2.29).高效液相色谱法(2.2.29)Test solution Dissolve 0.100 g of the substance to be examined in the mobile phaseand dilute to 100.0 mL with the mobile phase.供试品溶液：精密称取供试品0.100g，置100ml容量瓶中，用流动相溶解并定量稀释至刻度，即得。Reference solution (a) Dilute 0.5 mL of the test solution to 100.0 mL with the mobilephase.对照溶液a:精密量取供试品溶液0.5ml置100ml容量瓶中，用流动相定量并稀释至刻度，即得。Reference solution (b) Dilute 1.0 mL of reference solution (a) to 10.0 mL with themobile phase.对照溶液b:精密量取对照溶液a1.0ml,置10ml容量瓶中，用流动相定量并稀释至刻度，即得。Reference solution (c) Dissolve 5 mg of chlorphenamine impurity C CRS in 5 mL ofthe test solution and dilute to 50.0 mL with the mobile phase. Dilute 2