文档介绍：Chlorphenamine Maleate
马来酸***苯那敏
General Notices
总体概述
(Ph. Eur. monograph 0386)
C20H23ClN2O4 113-92-8
Action and use
使用及用途
Histamine H1 receptor antagonist; antihistamine.
组***H1受体拮抗剂;抗组***药。
Preparations
制剂
Chlorphenamine Injection
马来酸***苯那敏注射液
Chlorphenamine Oral Solution
马来酸***苯那敏口服溶液
Chlorphenamine Tablets
马来酸***苯那敏片
Ph Eur
DEFINITION
定义
(3RS)-3-(4-Chlorophenyl)-N,N-dimethyl-3-(pyridin-2-yl)propan-1-amine hydrogen (Z)-
butenedioate.
(3RS)-3-(4-***苯基)-N,N-二***-3 -(2-吡啶基)丙烷-1-***氢(Z)—butenedioate。
Content
含量
per cent to per cent (dried substance).
~%(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(%)
IDENTIFICATION
鉴别
A. Melting point (): 130 °C to 135 °()130℃-135℃
B. Infrared absorption spectrophotometry ().Comparison chlorphenamine maleate CRS. 红外光吸收光谱()与马来酸***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 g in water R and dilute to mL with the same solvent.
,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 () and not more intensely coloured than reference solution BY6(, Method II).溶液S应澄清无色;如显色,与BY6比较不得更深。
Optical rotation ()旋光度
-° to + °, determined on