Objective: To establish the uncertainty evaluation model of determination of aluminum hydroxide (or aluminum phosphate) from General Chapter 3106 in Chinese Pharmacopoeia 2020, and calculate the model using the aluminum adjuvant vaccine as an example. Methods: The sources of uncertainty affecting the measurement results were analyzed and evaluated, according to the specifications such as JJP1059.1-2012 Evaluation and expression of measurement uncertainty. And the combined uncertainty was calculated based on the established uncertainty evaluation model as an example. Results: The model wasestablished throughanalysis of uncertainty components from the measurement method, whilestringent acceptan ce stan dard and relaxed acceptan ce stan dard wereintroduced in the expanded uncertainty result judgment. The uncertainty introduced by the calibrated concentration of zinc titrant and the volume of consumed titrant were the main sources, according to calculation results of the example. Conclusion: All aluminum adjuvant vaccines and other aluminum-containing preparations,using the same method for aluminum content determination, are able toevaluate the measurement uncertainty on the basis of this model.The result judgment can be more reasonable and the uncertainty reduction can be more effectively, consequentlyto guidethe testing workin a more targeted way and offer useful references to evaluate the measurement uncertainty of capacity analysis.
LI Yu-li, SHAO Tian-shu, LIU Qi, LI Xiang, MA Yi-xing, LI Wen-dong
. Evaluation of the uncertainty of aluminum content determination for aluminum adjuvant vaccine in Chinese Pharmacopoeia[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(8)
: 1457
-1464
.
DOI: 10.16155/j.0254-1793.2022.08.20
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