摘要
目的:建立注射用盐酸吉西他滨的细菌内毒素检查方法。方法:根据《中国药典》2010年版细菌内毒素检查法,采用2个不同厂家的鲎试剂对注射用盐酸吉西他滨通过调节pH值及稀释等方法进行干扰试验和细菌内毒素检查。结果:样品溶液稀释为3.5mg/ml、pH值调节至7.0时对检查无干扰;细菌内毒素限值确定为0.10EU/mg。结论:注射用盐酸吉西他滨采用细菌内毒素检查法代替热原检查法可行。
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 3.5mg/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.
出处
《中国药房》
CAS
CSCD
2013年第1期76-77,共2页
China Pharmacy
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
Gemcitabine hydrochloride for injection
Bacterial endotoxin
Dilute
pH value
Interference test