制药用水电导率的测量不确定度评定

Evaluation of uncertainty in measurement of pharmaceutical water conductivity

利用电导率仪,采用《中国药典》2020年版方法测定制药用水电导率,并对电导率的测量不确定度进行评定。按照JJF 1059.1—2012等的要求,对电导率测定过程中各个环节影响因素分析、评估,列举出各影响因素的不确定度贡献,最终对制药用水电导率测定方法的不确定度进行合成。结果表明:按照该药典对制药用水电导率的要求,得到电导率均值为0.87μS/cm,扩展不确定度为0.06μS/cm,取包含因子k=2,制药用水电导率不确定度测定结果为(0.87±0.06)μS/cm,k=2。科学地表达制药用水电导率测定结果的可靠性和置信度。

The pharmaceutical water conductivity was determined by conductivity meter with the method of ChP(2020 edition),and the uncertainty of conductivity measurement was evaluated.According to the requirements of JJF 1059.12012,the influencing factors of each link in the conductivity determination process were analyzed and evaluated,and the contribution of uncertainty of each influencing factor was listed.Finally,the uncertainty of the conductivity determination method for pharmaceutical water was synthesized.Results showed that:according to the requirements of the ChP(2020 edition)for the conductivity of pharmaceutical water,the average conductivity is 0.87μus/cm,the expanded uncertainty is 0.06μus/cm,the inclusion factor k=2,the uncertainty of pharmaceutical water is(0.87±0.06)μS/cm,k=2.To scientifically express the reliability and confidence of the conductivity measurement results of pharmaceutical water.