摘要
目的:建立奥拉西坦原料药的细菌内毒素检查方法。方法:采用凝胶法,用两个不同厂家生产的鲎试剂,对3批样品进行干扰试验,并进行内毒素检查。结果:细菌内毒素限值定为“每1 mg奥拉西坦中含内毒素的量应小于0.01 EU”,对3批次奥拉西坦原料药样品进行细菌内毒素检查,结果均符合规定。结论:所建立的细菌内毒素检查方法,可用于奥拉西坦原料药细菌内毒素检查。
Objective:To establish a method for bacterial endotoxin test of oxiracetam active pharmaceutical in gredients(API).Methods:The interference test and bacterial endotoxins test of three batch samples of oxiracetam API were performed with TALs from two manufacturers,and the bacterial endotoxins of samples were tested and the results were judged.Results:The limit value of bacterial endotoxins was set as‘No more than 0.01 Endotoxin Unit/mg of oxiracetam’.The test results of the bacterial endotoxins in 3 batches of samples met the criteria.Conclusion:The established method can be used for bacterial endotoxin test of oxiracetam API.
作者
张昦昉
卢海霞
王钧
刘畅
葛泽勋
李立坤
ZHANG Haofang;LU Haixia;WANG Jun;LIU Chang;GE Zexun;LI Likun(Jilin Institute for drug control,Changchun 130033,China)
出处
《中国药品标准》
CAS
2023年第3期295-298,共4页
Drug Standards of China
关键词
奥拉西坦
原料药
细菌内毒素
干扰试验
凝胶法
oxiracetam
active pharmaceutical ingredient
bacterial endotoxins test
interference test
gel method
