Reviewgold2013

Measurement uncertainty in pharmaceutical analysis and its application

Marcus Augusto Lyrio Traple · Alessandro Morais Saviano · Fabiane Lacerda Francisco · Felipe Rebello Lourenço

62 citations0/0 files storedJournal of Pharmaceutical Analysis

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Scientific Measurement and Uncertainty Evaluation Analytical Methods in Pharmaceuticals Pharmaceutical studies and practices

Abstract

The measurement uncertainty provides complete information about an analytical result. This is very important because several decisions of compliance or non-compliance are based on analytical results in pharmaceutical industries. The aim of this work was to evaluate and discuss the estimation of uncertainty in pharmaceutical analysis. The uncertainty is a useful tool in the assessment of compliance or non-compliance of in-process and final pharmaceutical products as well as in the assessment of pharmaceutical equivalence and stability study of drug products.

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2006GUIDE TO THE EXPRESSION OF UNCERTAINTY IN MEASUREMENT 2004Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001 2012Quantifying Uncertainty in Analytical Measurement 2006Uncertainty sources in UV-Vis spectrophotometric measurement

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