Evaluation of Uncertainty of pH Measurement in Pharmaceuticals by Monte Carlo Method
HONG Xiao-xu1, WANG Yu2*, WU Li2, LUO Guo-an3, TANG Su-fang4, MAO Xiang-jun5, JIN Gui-min1
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1. Chinese Pharmacopoeia Commission, Beijing 100061, China; 2. Jiangsu Institute for Food and Drug Control, Nanjing 210008, China; 3. Department of Chemistry, Tsinghua University, Beijing 100001, China; 4. Tianjin Institute for Drug Control, Tianjin 300070, China; 5. Guizhou Institute for Food and Drug Control, Guiyang 550004, China
OBJECTIVE To evaluate the uncertainty of pH measurement in pharmaceuticals. METHODS Taking glucose and sodium chloride injection as an example, the uncertainty of pH measurement in pharmaceuticals was evaluate by uncertainty transmission rule's method (GUM) and Monte Carlo method (MCM), and the uncertainties obtained by the two methods were compared. RESULTS The measurement uncertainty obtained by GUM almost agreed with that by MCM. CONCLUSION MCM is easy and reliable, and can be used as an alternative method for evaluation of the measurement uncertainty in pharmaceutical analysis.
HONG Xiao-xu,WANG Yu*,WU Li,LUO Guo-an,TANG Su-fang,MAO Xiang-jun,JIN Gui-min.
Evaluation of Uncertainty of pH Measurement in Pharmaceuticals by Monte Carlo Method[J]. Chinese Pharmaceutical Journal, 2017, 52(8): 671-674 https://doi.org/10.11669/cpj.2017.08.013
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