Influence of method validation parameters in the measurement uncertainty estimation by experimental approaches in food preservatives analysis

2019 ◽  
Vol 282 ◽  
pp. 147-152 ◽  
Author(s):  
Luciano Molognoni ◽  
Heitor Daguer ◽  
Iara Regina dos Santos ◽  
Juliano De Dea Lindner
2016 ◽  
Vol 99 (3) ◽  
pp. 612-617 ◽  
Author(s):  
Fabiane Lacerda Francisco ◽  
Alessandro Morais Saviano ◽  
Felipe Rebello Lourenço

Abstract Investigation of out-of-specification analytical results is laborious, time-consuming, and costly and must be well documented. However, an analytical result is not complete unless reported with its measurement uncertainty. Here, we compare four different approaches for measurement uncertainty estimation used in acetaminophen quantification in pharmaceutical drug products. Measurement uncertainties were estimated using a repeatability and reproducibility study, Eurachem/Citac guidelines, Monte Carlo simulations, and a spreadsheet method. These different approaches provided similar results. However, they differed by the sources of uncertainties considered, by the procedures of calculation, and by the effort required in routine applications. Nevertheless, all four approaches were successful in assessing conformity of acetaminophen content in pharmaceutical drug products and may be used in assessing pharmaceutical equivalence.


Measurement ◽  
2013 ◽  
Vol 46 (1) ◽  
pp. 572-581 ◽  
Author(s):  
E. Balestrieri ◽  
M. Catelani ◽  
L. Ciani ◽  
S. Rapuano ◽  
A. Zanobini

Sign in / Sign up

Export Citation Format

Share Document