费休氏法测定注射用头孢曲松钠水分的不确定度评定

Evaluation of uncertainty for water determination of Ceftriaxone sodium for injection by Fischer's method

目的建立费休氏法测定注射用头孢曲松钠的水分的不确定度评定。方法建立数学模型,对水分测定过程中各影响因素进行分析评估。结果通过计算各变量的不确定度,合成不确定度,得出水分测定的扩展不确定度为0.13%(k=2)。结论该评定方法适用于费休氏法测定注射用头孢曲松钠水分的不确定度评定。

OBJECTIVE To establish a method of uncertainty evaluation for the water determination of Ceftriaxone Sodium for Injection by Fischer＇s method.METHODS The uncertainty was evaluated by an established mathematical model and the analysis of various factors affecting sample detection.RESULTS Each component of uncertainty was calculated and then the combined uncertainty was finally obtained by synthesizing the uncertainties of various component variables.The expanded uncertainty was calculated as 0.13%（k=2）.CONCLUSION This method is appropriate to be used in the uncertainty evaluation for the water determination of Ceftriaxone Sodium for Injection by Fischer＇s method.