中国药房2013，Vol.24Issue(1)：76-77,2.DOI:10.6039/j.issn.1001-0408.2013.01.27
注射用盐酸吉西他滨细菌内毒素检查方法的研究
Study on the Test Method of Bacterial Endotoxin in Gemcitabine Hydrochloride for Injection
摘要
Abstract
OBJECTIVE: To establish a method for testing the bacterial endotoxin in Gemcitabine hydrochloride for injection. METHODS: According to the bacterial endotoxin test stated on Chinese Pharmacopeia (2010 edition), interference test and bacterial endotoxin test were carried out by using TAL from 2 manufacturers to adjust the pH value of Gemcitabine hydrochloride for injection and dilute Gemcitabine hydrochloride for injection. RESULTS: No interference was found in the bacterial endotoxin test after Gemcitabine hydrochloride for injection was diluted at 3.5 mg/ml with pH value of 7.0. The endotoxin limit of it was 0.10 EU/mg. CONCLUSION: It is feasible for bacterial endotoxin test instead of pyrogen test of Gemcitabine hydrochloride for injection.关键词
注射用盐酸吉西他滨/细菌内毒素检查/稀释/pH值/干扰试验Key words
Gemcitabine hydrochloride for injection: Bacterial endotoxin/ Dilute/ pH value/ Interference test分类
医药卫生引用本文复制引用
周梅,武谷..注射用盐酸吉西他滨细菌内毒素检查方法的研究[J].中国药房,2013,24(1):76-77,2.
