Study on Bacterial Endotoxins Test for L-Oxiracetam Injection / 中国药师

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 .