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 Monte Carlo method. The particular and total risks of false acceptance decisions (consumers’ risks) were also estimated by 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.
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