注射用二乙酰氨乙酸乙二胺细菌内毒素检查方法验证

目的： 建立注射用二乙酰胺乙酸乙二胺的细菌内毒素的检查方法。方法：按《中国药典》2015年版四部通则1143进行，用不同厂家的鲎试剂对不同批号的注射用二乙酰氨乙酸乙二胺进行干扰试验和细菌内毒素检查。结果：用细菌内毒素检查用水将本品稀释至96倍时，用灵敏度0.25 EU·mL^-1的鲎试剂检查细菌内毒素，无干扰作用，按拟定标准检查，该品种3批样品细菌内毒素检查结果均符合规定。结论：本品可采用细菌内毒素检查法检查，其细菌内毒素限值（L）为0.12 EU·mg^-1。

Validation of the Detection Method for Bacterial Endotoxins in Ethylenediamine Diaceturate for Injection

Objective: To establish a detection method for bacterial endotoxins in ethylenediamine diaceturate for injection. Methods: Interference test and bacterial endotoxin inspection were performed on ethylenediamine diaceturate for injection with different batch numbers by using limulus reagents from different manufacturers according to general rule 1143 of Chinese Pharmacopoeia 2015 Vol. IV. Results: The products were diluted with BET water to 96 times, bacterial endotoxins were detected by using limulus reagent with a sensitivity of 0.25 EU·mL^-1 and no interference was detected. The bacterial endotoxin test results of the 3 batch samples met the requirement of the proposed standard inspection. Conclusion: Bacterial endotoxin detection method can be used to test the product, and the bacterial endotoxin limit (L) is 0.12 EU·mg^-1.