Renan Simabukuro 1 , Noh Ah Jeong 1 , Felipe Rebello Lourenço 1 Show Affiliations »
Abstract
BACKGROUND: Conformity assessment in pharmaceutical drug products usually are based on analytical results. An analytical result always is associated with an uncertainty which must be considered in a compliance assessment. OBJECTIVE: The objective of the present project aims to estimate the measurement uncertainty associated with the results of average weight, assay, uniformity of content, and dissolution testing in ranitidine tablets manufactured by two different companies (X and Y). METHODS: The uncertainty was evaluated using the Monte Carlo method. The particular and total risks of false acceptance decisions (consumers' risks) were also estimated by the Monte Carlo method. RESULTS: The results for ranitidine tablets manufactured by company X were (359.2 ± 2.7) mg of average weight, (108.6 ± 1.6)% of assay, (11.4 ± 2.8) of acceptance value for uniformity of content, and (89.4 ± 1.3)% for dissolution testing. The results for company Y were (312.5 ± 0.9) mg, (107.0 ± 1.4)%, (7.2 ± 1.7), and (93.6 ± 1.3)%, respectively. A 95% confidence level was adopted. According to results obtained from the Monte Carlo simulations, the results of average weight, assay of ranitidine, and uniformity of content are significantly correlated due to shared analytical steps. The correlation between values significantly affected the risk of false decisions. CONCLUSIONS: Consumers' risks were estimated for both ranitidine tablets and their results ensure compliance for ranitidine tablets manufactured by companies X and Y. HIGHLIGHTS: The use of measurement uncertainty is an important issue regarding the conformity/non-conformity assessment of pharmaceutical products. © AOAC INTERNATIONAL 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.
BACKGROUND: Conformity assessment in pharmaceutical drug products usually are based on analytical results. An analytical result always is associated with an uncertainty which must be considered in a compliance assessment. OBJECTIVE: The objective of the present project aims to estimate the measurement uncertainty associated with the results of average weight, assay, uniformity of content, and dissolution testing in ranitidine tablets manufactured by two different companies (X and Y). METHODS: The uncertainty was evaluated using the Monte Carlo method. The particular and total risks of false acceptance decisions (consumers' risks) were also estimated by the Monte Carlo method. RESULTS: The results for ranitidine tablets manufactured by company X were (359.2 ± 2.7) mg of average weight, (108.6 ± 1.6)% of assay, (11.4 ± 2.8) of acceptance value for uniformity of content, and (89.4 ± 1.3)% for dissolution testing. The results for company Y were (312.5 ± 0.9) mg, (107.0 ± 1.4)%, (7.2 ± 1.7), and (93.6 ± 1.3)%, respectively. A 95% confidence level was adopted. According to results obtained from the Monte Carlo simulations, the results of average weight, assay of ranitidine , and uniformity of content are significantly correlated due to shared analytical steps. The correlation between values significantly affected the risk of false decisions. CONCLUSIONS: Consumers' risks were estimated for both ranitidine tablets and their results ensure compliance for ranitidine tablets manufactured by companies X and Y. HIGHLIGHTS: The use of measurement uncertainty is an important issue regarding the conformity/non-conformity assessment of pharmaceutical products. © AOAC INTERNATIONAL 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Entities: Chemical
Year: 2021
PMID： 33156342 DOI： 10.1093/jaoacint/qsaa151
Source DB: PubMed Journal: J AOAC Int ISSN： 1060-3271 Impact factor: 1.913