Biological Safety Test Methods for Reduced Glutathione for Injection
- VernacularTitle:注射用还原型谷胱甘肽生物安全性检查方法
- Author:
Na LIU
;
Xia WEI
;
Fengjia ZHENG
;
Chunfang WANG
;
Qingfen ZHU
- Publication Type:Journal Article
- Keywords:
Reduced glutathione;
Bacterial endotoxin;
Abnormal toxicity
- From:
China Pharmacist
2016;19(6):1208-1211
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the bacterial endotoxin test method and the abnormal toxicity test method for reduced glutathi -one for injection.Methods:According to the requirements and methods in Chinese Pharmacopoeia (2015 edition, part IV), the bacte-rial endotoxin test and the abnormal toxicity test for reduced glutathione were studied .Results:The limit of bacterial endotoxin for re-duced glutathione was 0.125 EU· mg-1 , and the limit of abnormal toxicity was 1.0 g· kg-1 .Conclusion: The bacterial endotoxin test method and the abnormal toxicity test method are feasible .The abnormal toxicity should be supplemented in the quality standard for reduced glutathione , and the bacterial endotoxin test can replace the pyrogen test .
