富马酸伊布利特注射液细菌内毒素检查法研究

The bacterial endotoxins test method for ibutilide fumarate injection

目的:建立富马酸伊布利特注射液的细菌内毒素检查方法。方法:按《中国药典》2015年版四部通则进行试验。结果:富马酸伊布利特注射液稀释10倍时对细菌内毒素检查无干扰,细菌内毒素限值为25EU·mg^-1。对3批富马酸伊布利特注射液进行检查,结果均符合规定。结论:所建立的细菌内毒素检查法可用于富马酸伊布利特注射液的细菌内毒素检查。

Objective : To establish a bacterial endotoxins test method for ibutilide fumarate injection. Methods :The experiment was carried out and the results were judged according to general notice of Chinese Pharmacopeia 2015 Volume Ⅳ. Results : There was no interference on bacterial endotoxins test when ibutilide fumarate injection was diluted for 10 times. The limit value of the bacterial endotoxin was 25 EU·mg^-1 . The test results of bacterial endotoxin in 3 batches of samples met the requirement. Conclusion : The established method can be used for bacterial endotoxin test for ibutilide fumarate injection.