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Study on the test method of the bacterial endoroxin in Imipenem and Cilasatin Sodium for Injection
Author(s): 
Pages: 667-669
Year: Issue:  11
Journal: QILU PHARMACEUTICAL AFFAIRS

Keyword:  亚胺培南西司他丁钠细菌内毒素检查;
Abstract: 目的 研究注射用亚胺培南西司他丁钠细菌内毒素的检查法.方法 用两个不同生产厂家、不同标示灵敏度鲎试剂进行研究,按《中国药典》2005年版(二部)附录ⅪE进行试验和结果判断.结果 注射用亚胺培南西司他丁钠的最大不干扰浓度为 1.47mg·ml-1,对两个不同厂家六批样品进行检查均无干扰作用,其细菌内毒素均小于0.17EU·mg-1. 结论本品细菌内毒素检查法(凝胶法)控制细菌内毒素的含量可行.
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