摘要
目的:建立叔丁醇细菌内毒素检查方法。方法:采用2个不同厂家的鲎试剂和3批样品,进行预干扰试验和干扰试验。结果:供试品溶液对鲎试剂与细菌内毒素之间的凝集反应无干扰;样品的细菌内毒素限值确定为0.25 EU·ml-1。结论:所建立的方法可行,可用于叔丁醇的细菌内毒素检查。
Objective: To establish a method for the detection of bacterial endotoxins in tertiary butyl alcohol. Methods: The interference experiment and bacterial endotoxins test for 3 batches of the products from 2 companies were carried out with tachypleus amebocyte lysate. Results: There was no interference in the bacterial endotoxins test. The limit of bacterial endotoxins was 0. 25 EU / ml.Conclusion: The established method of bacterial endotoxins test is feasible for tertiary butyl alcohol.
出处
《中国药师》
CAS
2015年第4期674-676,共3页
China Pharmacist
关键词
叔丁醇
细菌内毒素
鲎试剂
干扰试验
Tertiary butyl alcohol
Bacterial endotoxins
Tachypleus amebocyte lysate
Interference experiment