ArticleScientific reports2022
Evaluation of color changes during stability studies using spectrophotometric chromaticity measurements versus visual examination.
Article in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 32 citations in OpenAlex.
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- Investigating pharmaceutical product recalls due to discolouration: a Kenyan case review (January 2016-December 2024).Journal of pharmaceutical policy and practice · 2025Article
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- Thermal Compatibility of New ACEI Derivatives with Popular Excipients Used to Produce Solid Pharmaceutical Formulations.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Hypotensive and Cardioprotective Potential of Yellow Bedstraw Extract-Based Oral Liquid in Spontaneously Hypertensive Rats.International journal of molecular sciences · 2024Article
- Newly Developed Semi-Solid Formulations ContainingPharmaceutics · 2024Article
- A Guide to Best Practice in Sensory Analysis of Pharmaceutical Formulations.Pharmaceutics · 2023Article
- Tunable Heteroaromatic Nitriles for Selective Bioorthogonal Click Reaction with Cysteine.Bioconjugate chemistry · 2023Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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