Establishment of Bacterial Endotoxin Test Method for Peramivir Hydrate and Sodium Chloride Injection
10.6039/j.issn.1001-0408.2015.27.39
- VernacularTitle:帕拉米韦氯化钠注射液细菌内毒素检查方法的建立
- Author:
Shiqin QIAO
;
Zhuye SUN
;
Weigang LI
;
Lilei WU
- Publication Type:Journal Article
- Keywords:
Peramivir hydrate and sodium chloride injection;
Bacterial endotoxin test;
Gel method;
Interference test
- From:
China Pharmacy
2015;(27):3853-3854
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for bacteria1 endotoxin test for Peramivir hydrate and sodium chloride injec-tion. METHODS:Maximum non-interference concentration of the sample with different batohes were used for interference test. was determined by interference test according to endotoxin gel method stated in Chinese Pharmacopiea (2010 edition)and bacterial en-edotoxintest by tachypleus amebocyte lysate from 2 manufact urers. RESULTS:The interference on bacterial endotoxin test could be excluded when the sample was diluted to 2.5 mg/ml and the limit of bacterial endotoxins was 0.5 EU/ml. CONCLUSIONS:The established method can be used to detect the bacterial endotoxin of Peramivir hydrate and sodium chloride injection.
