Case Study: Pharmaceutical tablet discoloration
The Challenge
A client was developing a pressed tablet for a pharmaceutical blend and observed randomly distributed discoloration throughout the tablet, which should be a uniform color. The formulation was a complex blend of ingredients, so identifying the cause was too complicated to troubleshoot on their own. It was unclear if the discoloration was a result of contamination, formulation, processing, or something else. We stepped in to help find the source and suggest modifications to prevent future issues.
Our Approach
When investigating foreign material issues, our scientists always start with a visual and microscopic inspection. First, we broke up the tablet and found a random distribution and sizing of the discoloration both inside and outside. Microscopically, we couldn't see a clear morphological difference between the light and dark parts of the tablet. We isolated some of the dark spots and compared their FTIR spectrum with non-discolored spots from the same tablet and a control tablet. There was no noticeable difference between the spectra, so we used EDXA to analyze the elemental composition of the dark spots and the control tablets.
The Solution
With EDXA, we noticed variation in titanium (TiO2) concentrations, suggesting that the titanium in the formulation clumped together during processing. Titanium is very light-sensitive, so clumping can result in potential light degradation and subsequent discoloration. We worked with our client to modify their manufacturing methods, and they were able to avoid future issues.
Our Team
Eurofins SF Analytical is renowned for successfully investigating the most challenging problems in food, beverages, and packaging; including product recall support, insurance, and legal investigation. Our experts’ range of expertise from microbiology to analytical chemistry coupled with years of experience makes them the ideal team for foreign material and contamination investigations. Click here to connect with an expert, or visit our website to learn about the full range of offerings.
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