马来酸氯苯那敏BP2015翻译

Chlorphenamine Maleate

马来酸氯苯那敏

General Notices

总体概述

(Ph. Eur. monograph 0386)

C20H23ClN2O4 390.9 113-92-8

Action 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 Eur

DEFINITION

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 chlorphenamine maleate 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 phase and 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 the mobile 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 of the test solution and dilute to 50.0 mL with the mobile phase. Dilute 2 mL of this solutionto 20 mL with the mobile phase.

对照溶液c：精密量取杂质C 对照品5mg，置50.0ml容量瓶中，用5ml的供试品溶液溶解，加入流动相溶解并稀释至刻度，摇匀。再取该溶液2ml置20ml容量瓶中，并用流动相溶解并稀释至刻度，即得。

Reference solution (d) Dissolve 5 mg of 2,2¢-dipyridylamine R (impurity B) in the mobile phase and dilute to 100 mL with the mobile phase.

对照溶液d:精密量取5mg的杂质B 置100ml的容量瓶中，用流动相溶解并定量稀释至刻度即得。

Reference solution (e) Dissolve the contents of a vial of chlorphenamine impurity A CRS in 2 mL of the test solution. Sonicate for 5 min.

对照溶液e:精密量取含有杂质A的对照品，用2ml的供试品溶液溶解，超声5分钟。Column:柱

—size: l = 0.30 m, Ø = 3.9 mm;尺寸