左乙拉西坦氯化钠注射液细菌内毒素检查法方法学验证

Detection Vadidation of Bacterial Endotoxin Test on Levetiracetam Sodium Chloride Injection

目的对左乙拉西坦氯化钠注射液细菌内毒素检查法进行方法学验证。方法采用《中国药典》2010年版附录细菌内毒素检查法。结果左乙拉西坦浓度在2.5 mg.ml-1,用灵敏度为0.125 EU.ml-1的鲎试剂检测细菌内毒素无干扰。结论左乙拉西坦氯化钠注射液可用鲎试剂进行细菌内毒素检查。

Objective To vadidate the detection method of bacterial endotoxin test on levetiracetam NaCl injection.Methods The experiment was conducted according to the bacterial endotoxin test specified in Chinese pharmacopoeia（2010 edition）.Results It was proved that the maximum noninterference concentration was 2.5 mg · ml-1 and the sensitivity of TAL was 0.125 EU · ml-1.Conclusion Bacterial endotoxin test is suitable for endotoxin detection of levetiracetam sodium chloride injection.