中国药业2016，Vol.25Issue(22)：69-71,3.
盐酸伊立替康注射液的细菌内毒素检查方法研究
Study on the Bacterial Endotoxin Test Method for Irinotecan Hydrochloride Injection
王婷婷 1李亘 1周瑞2
作者信息
- 1. 江苏省连云港市药品检验所，江苏 连云港 222006
- 2. 正大天晴药业集团股份有限公司，江苏 连云港 222006
- 折叠
摘要
Abstract
Objective To establish the bacterial endotoxin test method of irinotecan hydrochloride injection. Methods According to the appendix of Chinese Pharmacopoeia(2015 edition)1143 gel method for he bacterial endotoxin test,maximal non-interference concentra-tions of samples were determined by pre-interference test and interference test,then the methodology validation was conducted. Results There was no interference on bacterial endotoxin test when the sample pH was adjusted to 6. 0-7. 0 with Alkaline regulatorⅡand concentration diluted to 0. 95 g/L with BET water. Conclusion The established method is feasible to detect the bacterial endo-toxin of irinotecan hydrochloride injection.关键词
盐酸伊立替康注射液/细菌内毒素检查/凝胶法/干扰试验Key words
irinotecan hydrochloride injection/bacterial endotoxin test/gel-clot/interference test分类
医药卫生引用本文复制引用
王婷婷,李亘,周瑞..盐酸伊立替康注射液的细菌内毒素检查方法研究[J].中国药业,2016,25(22):69-71,3.
