An eye toward setting pharmaceutical color specifications in the future
European and United States Pharmacopeia liquid color standards (EP and USP) are typically used in the pharmaceutical industry to assign a color rating to liquid samples indicative of their product quality. The original intent of using EP and USP color was to improve color communication over more ambiguous word descriptors such as 'slightly yellow' by visual comparison to a fixed set of transparent liquid color standards. An increase in yellowness can be a quality indicator of degradation over time in shelf life studies, presence of impurities, process change variation, and inconsistencies in incoming components that leads to variation in the final product.
Challenges with this current method include variability in making up the standard color solutions, subjectivity in picking the best match color, and because there are greater differences in color as color gets more intense, difficulty in visually differentiating between colors at low intensities.
This raises the question – is there a more precise method to determine a drug products color?
The answer to this question is yes. Quantitative color determination methods offer multiple improvements over current visual assessment methods. Quantitative methods describe relative perception of color standards by using 'Color Space' as a specification, providing greater insight into lot-to-lot variability, precise color tracking of multiple lots, and even counterfeit detection. Quantitative Color Measurement is more precise and able to discern several times finer than human visual evaluation, and can be used to verify color quality in liquid APIs and excipients, concentrated liquid proteins or any liquid that has a tendency to become yellow at the raw material, intermediate and final product stages.
Sign up now for this this 45-minute webinar which will discuss tools to help biotech and pharmaceutical companies realize greater performance by moving from qualitative visual color assessment to quantitative color determination, helping them to know 'what color their drug solution' really is.
Presented by
Paul Barnes,
Product Manager – HunterLab
Paul Barnes is currently Product Manager with HunterLab. He has 28 years of experience in the analytical and quality control instrument industry highlighted by 21 years in the design, applications, sales, and marketing of instruments for color and appearance measurement. He joined HunterLab in 1995.
Paul has spoken on color theory plus the industrial and commercial applications of color measurement throughout the pharmaceutical and biotech industries.
He holds a B.S. in Chemistry for the University of Maryland College Park and a M.S. in Marketing from Johns Hopkins University.