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 examination using color reference solutions and to lightness and chromaticity measurement to determine their specific color by UV–Vis spectrophotometry. The color of paracetamol solutions changed faster when exposed to stress condition (light), as did the PNS when exposed to heat. In both cases, color variations were detected earlier and more precisely by UV–Vis spectrophotometry than by visual examination. Color measurement using an UV–Vis spectrophotometry should advantageously replace visual examination when assessing colors changes during drug stability studies.