Measurement uncertainty evaluation from correlated validation data: Determination of elemental impurities in pharmaceutical products by ICP-MS

Multivariate guard-bands and total risk assessment on multiparameter evaluations with correlated and uncorrelated measured values

“…Measurement uncertainty associated with ciprofloxacin and acyclovir content was evaluated using bottom-up and/or top-down approaches (Separovic et al, 2023;Ellison, 2005;Milde et al, 2020;Morgado et al, 2021;Morgado et al, 2022;Pluháček et al, 2023). For the top-down approach, two main sources of uncertainty were considered: 1) the trueness component assessed as the mean recovery of samples with known concentrations of ciprofloxacin and acyclovir; and 2) the precision component assessed as the standard deviation of samples analyzed in repeatability conditions (Separovic et al, 2018;Separovic et al, 2023;Milde et al, 2020).…”