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(Reference retrieved automatically from SciELO through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Risk of false conformity decisions due to measurement uncertainty of Active Pharmaceutical Ingredient: A multiparametric evaluation

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Author(s):
Gustavo Kenji Toko Purcino do Amaral [1] ; Felipe Rebello Lourenço [2]
Total Authors: 2
Affiliation:
[1] University of Sao Paulo. School of Pharmaceutical Sciences. Departament of Pharmacy - Brasil
[2] University of Sao Paulo. School of Pharmaceutical Sciences. Departament of Pharmacy - Brasil
Total Affiliations: 2
Document type: Journal article
Source: Brazilian Journal of Pharmaceutical Sciences; v. 60, 2024-02-26.
Abstract

Abstract Medicines must be subject to physical, chemical, and biological analysis to guarantee their quality, safety, and effectiveness. Despite the efforts to ensure the reliability of analytical results, some uncertainty will always be associated with the measured value, which can lead to false decisions regarding conformity/non-conformity assessment. This work aims to calculate the specific risk of false decisions regarding conformity/non-conformity of acetaminophen oral solution dosage form. The acetaminophen samples from five different manufacturers (A, B, C, D, and E) were subject to an active pharmaceutical ingredient assay, density test, and dose per drop test according to the official compendia. Based on measured values and their respective uncertainties, the risk values were calculated using the Monte Carlo method implemented in an MS Excel spreadsheet. The results for two acetaminophen oral solution samples (C and D) provided an increased total risk value of false acceptance (33.1% and 9.6% for C and D, respectively). On the other hand, the results for the other three acetaminophen samples (A, B, and E) provided a negligible risk of false acceptance (0.004%, 0.025%, and 0.045% for A, B, and E, respectively). This indicates that measurement uncertainty is very relevant when a conformity assessment is carried out, and information on the risks of false decisions is essential to ensure proper decisions. (AU)

FAPESP's process: 22/08406-5 - Impact of sampling and analytical uncertainties on conformity assessment of pharmaceutical products
Grantee:Felipe Rebello Lourenço
Support Opportunities: Regular Research Grants