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注射用盐酸吉西他滨细菌内毒素方法验证

王春玲 李孝壁 颜磊亭 陈娟 朱凤姝

中国医药科学Issue(1):123-125,3.
中国医药科学Issue(1):123-125,3.

注射用盐酸吉西他滨细菌内毒素方法验证

Validation of bacterial endotoxin test method of gemcitabine hydrochloride for injection

王春玲 1李孝壁 1颜磊亭 1陈娟 1朱凤姝1

作者信息

  • 1. 江苏豪森医药研究院有限公司,江苏连云港222000
  • 折叠

摘要

Abstract

Objective Research and establish bacterial endotoxin test method of Gemcitabine Hydrochloride for Injection. Methods The test method was developed according to the bacterial endotoxin method of Appendix XI E in 2010 Edition of Chinese Pharmacopeia VolumeⅡ. Results In the validation conditions, the dilution method can be used to eliminate the interference in the test of Gemcitabine Hydrochloride for Injection. Conclusion This method can be used to test the bacterial endotoxin in Gemcitabine Hydrochloride for Injection.

关键词

注射用盐酸吉西他滨/细菌内毒素方法/验证

Key words

Gemcitabine hydrochloride for injection/Bacterial endotoxin method/Validation

分类

医药卫生

引用本文复制引用

王春玲,李孝壁,颜磊亭,陈娟,朱凤姝..注射用盐酸吉西他滨细菌内毒素方法验证[J].中国医药科学,2014,(1):123-125,3.

中国医药科学

2095-0616

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