乙酰半胱氨酸微生物限度方法学验证

Validation of Microbial Limit Methodology for N-acetylcysteine

目的:建立验证乙酰半胱氨酸的微生物限度检测方法。方法:用薄膜过滤法、平皿法验证所采用的方法是否适合该药品微生物限度检查方法。结果:需氧菌检查、控制菌检查采用薄膜过滤法,霉菌和酵母菌数检查采用平皿法,试验菌的回收率均在0.5~2.0范围内。结论:该方法可用于乙酰半胱氨酸的微生物限度检查。

Objective:Establishment of microbial limit test method for N-acetylcysteine.Methods:The membrane-filter method and plate method were used to verify whether the method adopted is suitable for the microbial limit test of the drug.Results:The total aerobic bacteria count and the control bacteria adopted the membrane-filter method,the total molds and yeasts count adopted the plate-count method.,The recoveries of the strains were all in the range of 0.5~2.0.Conclusion:This method can be used for the microbial limit test of N-acetylcysteine.