Extractables & Leachables – Elemental Impurity Testing

Extractables and Leachables

Most are aware that the packaging for pharmaceuticals must be free of unwanted impurities.  Not only do we wish to understand levels of impurities from a toxicological standpoint; but also, from the perspective of ensuring that the materials found within the packaging do not negatively impact the active ingredients (APIs) within the finished product.  This creates a need to test for extractable and leachable elemental impurities in these packaging materials.

While this seems simple on the surface, it’s more complicated than it sounds because the testing of elemental impurities in the diverse extraction fluids can be very complicated, time consuming and expensive.

Chemical Solutions has partnered with Chemic Laboratories Inc. to handle all aspects of extractable and leachable testing, thus providing our end customers with a single source solution.  While Chemic handles the initial extraction process, CSL then performs the elemental impurity testing, employing methods which we’ve tailored specifically for E&Ls.  These methods provide excellent quantitative analysis of your samples, while doing so in a streamlined manner, while minimizing the cost.

Learn more in this video.


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