Study on Bacterial Endotoxins Test of Topotecan Hydrochloride for Injection

OBJECTIVE　To establish a method for determination of the bacterial endotoxin in topotecan hydrochloride for injection. METHODS　According to Chinese Pharmacopoeia 2010 edition Appendix Ⅺ E bacterial endotoxin test. RESULTS　Dilution sample to 0.04 mg·mL^-1 had no interference to bacterial endotoxin test. The results of bacteria endotoxin test in three batchs all accorded with the standard of the quality control. CONCLUSION　It can be used instead of rabbit pyrogen test method for. The limits of bacterial endotoxin was 50 EU·mg^-1.