Evaluation of color changes during stability studies using spectrophotometric chromaticity measurements versus visual examination.

ABSTRACT: Stability studies are essential to be able to assign an expiration date to medications. Color variation is one of the organoleptic characteristics of actives substances or medications which can indicate the presence of contaminations, impurities or degradations products. However there is no data available comparing the often used visual examination with spectrophotometric measurements during stability studies. The aim of this study was therefore to evaluate precisely how different the two methods are, by comparing the change of color of two drug formulations chosen as models, assessed by visual examination versus a spectrophotometric colorimetric analysis. Paracetamol and parenteral nutrition solutions were stored in stress conditions for up to 46 days, and were subjected to a visual exami

SUBMITTER: Sakiroff LM 

PROVIDER: S-EPMC9142492 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature