Measurement uncertainty in pharmaceutical analysis and its application

J Pharm Anal. 2014 Feb;4(1):1-5. doi: 10.1016/j.jpha.2013.11.001. Epub 2013 Nov 20.

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.

Keywords: Measurement uncertainty; Method validation; Pharmaceutical analysis; Quality control.

Publication types

  • Review