Objective To set up a reasonable limit of bacterial endotoxin and establish a bacterial endotoxin test for rifampicin.Methods Reasonable endotoxin limits for rifampicin raw materials were calculated.And then the gel method was followed in accordance with the Chinese Pharmacopoeia 2020 edition of the four general rules 1143 bacterial endotoxin examination method.Interference tests were performed on three batches of raw material samples using horseshoe crab reagents from two manufacturers for the methodological validation of bacterial endotoxin in rifampicin raw materials.Results The endotoxin limit was set at 0.5 EU/mg in combination with the clinical use of rifampicin,and the test sample was dissolved in methanol and diluted to a mass concentration of not more than 0.5 mg/ml without interference with the results of the bacterial endotoxin test.Conclusion Establishing a method for the inspection of bacterial endotoxins in rifampicin raw materials,which is more conducive to the quality control of finished products and drug safety.
关键词
利福平原料/细菌内毒素/内毒素限值/难溶/干扰试验
Key words
Rifampicin raw material/Bacterial endotoxin/Endotoxin limit values/Insoluble/Interference test
维普
万方数据