Suitability of the Microbial Limit Test Methods for Roxithromycin Capsules
Objective To establish a microbial limit test method for Roxithromycin Capsules based on the microbial suitability test.Methods According to the requirements of the biological examination method in the general rule 1100 of the Chinese Pharmacopoeia(2020 Edition Volume Ⅳ),the recovery test was carried out by the plate-count method,membrane filtration method,and dilution-neutralization method to study the microbial counting and control bacterial test methods.Results Dilution-neutralization method combined with the membrane filtration method with membrane filtration could effectively remove the antimicrobial activity of roxithromycin,and the recovery rate could meet the requirements.Conclusion The established test method can meet the requirements of the Chinese Pharmacopoeia,and can be used as the microbial limit test method for Roxithromycin Capsules.
Roxithromycin Capsulesmicrobial method validationsuitability test of counting methodmembrane filtration method
万方数据
维普
