微生物检定法测定红霉素原料效价的不确定度分析

目的评定以微生物检定法测定红霉素原料含量的不确定度。方法根据《测量不确定度评定与表示》(JJFI059-1999)中有关规定,对红霉素原料的含量测定进行不确定度来源及大小进行分析和评定。结果扩展不确定度为24.34 U.mg-1,效价测定结果可表示为(988.6±24.34)U.mg-1。不确定度主要来源为方法设计,其次为溶液稀释。结论选择适宜的方法设计,尽可能减少稀释次数,可有效减小试验的不确定度。

Uncertainty analysis in the determination of erythromycin material by microbiological method

Objective To evaluate the uncertainty in erythromycin material by microbiological method.Methods The source and magnitude of uncertainty in the determination of erythromycin by microbiological method were analyzed and evaluated according to the standard in Evaluation and Expression of Uncertainty in Measurement（JJFl059-1999）.Results The expanded uncertainty was 24.34 U·mg-1,and the titer of the determination can be expressed for（988.6±24.34）U·mg-1.The main source of uncertainty was method design and next was solution dilution.Conclusion Selecting suitable method design and reducing the times of dilution can effectively reduce the uncertainty of experiment.