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目的对药品中pH测定的不确定度进行评定。方法以葡萄糖氯化钠注射液pH测定为例,分别采用基于不确定度传播律(GUM)法和基于蒙特卡洛(MCM)法评定pH测定的不确定度,用MCM法验证GUM法评定不确定度的可靠性。结果 GUM法和MCM法得到的测量结果以及不确定度基本一致。结论 MCM法用于不确定度评定,是一个简便、可靠,且适用性更广的可选择方法。
Objective To evaluate the uncertainty of pH determination in pharmaceuticals. Methods Taking the pH measurement of glucose and sodium chloride injection as an example, the uncertainty of the pH measurement was evaluated by the GUM method and the Monte Carlo method, respectively. The MCM method was used to evaluate the GUM method. Determine the degree of reliability. Results The results and uncertainties obtained by GUM method and MCM method are basically the same. Conclusion The MCM method is used to evaluate the uncertainty. It is an easy, reliable and applicable method.