氯法拉宾注射液细菌内毒素检查法的建立

Bacterial Endotoxin Test for Clofarabine Injection

摘要: 目的建立氯法拉宾注射液细菌内毒素检查方法。方法根据中国药典2005年版二部附录收载的细菌内毒素检查方法进行实验。结果氯法拉宾注射液稀释4倍以后，对细菌内毒素检查无干扰; 3批样品细菌内毒素检查均符合规定。结论细菌内毒素检查方法可用于该产品的质量控制。

Abstract: OBJECTIVE To establish bacterial endotoxin test method for clofarabine injection. METHODS The experiment was carried out according to the bacterial endotoxin test method indexed in the appendix of Ch.P(2005) Vol II. RESULTS After dilution 4 times, clofarabine injection showed no interference in the bacterial endotoxin test. The bacterial endotoxin tests of 3 batches of samples were all up to the standards. CONCLUSION The bacterial endotoxin test method can be applied in the quality control.