Objective To determine whether the microgel method can meet the requirements of Chinese Pharmacopoeia,as a supplement to the existing bacterial endotoxin test method.Methods According to the provisions of"9101 Guidelines for the validation of pharmaceutical quality analysis methods"in Part Ⅳ of the Pharmacopoeia of the People's Republic of China(2020 edition),the microgel method(5 μL samples+50 μL limulus ambocyte lysate)was analyzed for"specificity","limit of detection"and"durability"in the item of"Determination of impurities".The gel method and microgel method were used to compare 85 batches of samples for variety applicability and 384 batches of samples for consistency comparison.Results The microgel method was methodologically validated and showed that it met the requirements of the Pharmacopoeia of the People's Republic of China for the qualitative methods,and the microgel method was equivalent to the gel method for the comparison of the applicability and consistency of the varieties.Conclusion The microgel method can be promoted as a supplementary alternative to the gel method in China.
关键词
细菌内毒素/鲎试剂/微量凝胶法/方法学验证/品种适用性/一致性评价/补充方法
Key words
bacterial endotoxin/limulus ambocyte lysate(LAL)/microgel method/methodological validation/variety suitability/consistency comparison/complementary and alternative method
维普
万方数据