注射用尿促性素黄体生成素效价测定的不确定度评价

Uncertainty Evaluation of the Potency Testing of Luteinizing Hormone in Menotropins for Injection

目的:建立注射用尿促性素黄体生成素效价测定的不确定度评定方法。方法:通过建立评定注射用尿促性素黄体生成素效价测定不确定度的数学模型,分析其测定不确定的影响因素,并将各不确定度的分量进行量化分析,计算扩展不确定度。结果:注射用尿促性素黄体生成素效价测定的扩展不确定度为10.56%,其效价可表示为105.79%±10.56%(k=2)。结论:该方法适用于注射用尿促性素黄体生成素效价测定的不确定度评定。

Objective:To establish a method for the uncertainty evaluation of the potency testing of luteinizing hormone in menotropins for injection.Methods:Mathematical model was established for the potency testing of luteinizing hormone in menotropins for injection to analyze the influencing factors of uncertainty.The uncertainty components were quantitatively analyzed and the expanded uncertainty was calculated.Results:The expanded uncertainty of the potency testing of luteinizing hormone in menotropins for injection was 10.56%and the potency was 105.79%±10.56%(k=2).Conclusion:The method can be used for uncertainty evaluation of the potency testing of luteinizing hormone in menotropins for injection.