Study on Bacterial Endotoxins Test for L-Oxiracetam Injection
- VernacularTitle:左旋奥拉西坦注射液细菌内毒素检查方法的研究
- Author:
Hongping WANG
;
Meimei HUANG
;
Zuyuan RONG
- Publication Type:Journal Article
- Keywords:
L-Oxiracetam injection;
Bacterial endotoxins;
Tachypleus amebocyte lysate;
Interference test
- From:
China Pharmacist
2016;19(10):1993-1995
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a bacterial endotoxins testing method for L-oxiracetam injection. Methods: According to the gel-clot technique for bacterial endotoxin inspection and the related regulations in Chinese Pharmacopoeia (2015 edition, volume Ⅳ, general rule 1143), tachypleus amebocyte lysate (TAL) from two different manufacturers were used for bacterial endotoxins test on 3 batches of L-oxiracetam injection with methodology studies. Results:Diluted to 8. 3 mg·ml-1 , the samples showed no interference a-gainst the bacterial endotoxins test. Conclusion:The bacterial endotoxins test method for L-oxiracetam injection is applicable with the endotoxin limit of 3 EU·ml-1 .
