摘要
依据《中国药典》2 0 0 0年版二部“细菌内毒素检查法”及“细菌内毒素检查法应用指导原则” ,并参照《英国药典》2 0 0 0年版的要求 ,确定试验样品醋酸亮丙瑞林的细菌内毒素限值为 1 6 .7EU/mg。经对广西半宙制药有限公司生产的三批醋酸亮丙瑞林采用细菌内毒素检查法中的凝胶法进行干扰试验 ,确证样品的最大无干扰浓度为 1 5 μg/mL。
Objective: To establish a gelation method of bacterial endotoxin tests for leupropelin acetate. Methods: The maximum non disturbing concentration was obtained according to interference test for the substances being examined. Results and conclusion: Leupropelin could interfere the detection of bacterial endotoxin. When the concentration of the substance being examined was diluted to 15μg/ml, the interference between the sample and the TAL regent can be eliminated.
出处
《广东药学院学报》
CAS
2004年第1期21-23,共3页
Academic Journal of Guangdong College of Pharmacy
关键词
醋酸亮丙瑞林
细菌内毒素
干扰试验
leupropelin acetate
bacterial endotoxin
interference test
