摘要
目的:建立替尼泊苷注射液细菌内毒素的检查方法。方法:按2010年版《中国药典》附录细菌内毒素凝胶检查法的要求,通过干扰试验确定样品最大不干扰质量浓度,并进行方法学验证。结果:样品稀释至质量浓度0.02 mg/ml(λ=0.25 EU/ml)或0.01mg/ml(λ=0.125 EU/ml)以下时对细菌内毒素检查法无干扰作用。结论:所建立的方法可用于替尼泊苷注射液的细菌内毒素检查。
OBJECTIVE:To establish a method for bacterial endotoxin test of Teniposide injection. METHODS:Maximum noninterference concentration of sample was determined by interference test according to bacterial endotoxins gel-clot test stated in the appendix of Chinese Pharmacopeia(2010 edition). And then methodology validation was conducted. RESULTS:The interference on bacterial endotoxin test can be excluded when sample was diluted to below 0.02 mg/ml(λ =0.25 EU/ml)or 0.01 mg/ml(λ=0.125 EU/ml). CONCLUSIONS:The established method is feasible to detect the bacterial endotoxin of Teniposide injection.
出处
《中国药房》
CAS
CSCD
2014年第41期3914-3916,共3页
China Pharmacy
关键词
替尼泊苷注射液
细菌内毒素检查
凝胶法
干扰试验
Teniposide injection
Bacterial endotoxin test
Gel-clot test
Interference test