Extractables and leachables (E/L) studies are designed to identify and quantify substances which could leach from pharmaceutical container closure systems and packaging into pharmaceutical products. As packaging material can be extremely complex, it is critical that E/L analytical studies be designed specifically for your drug product and the container materials. A profile of extractable components must be obtained to identify potential sources of leachables, after which formal leachables studies can be performed.  In both cases, toxicological risk assessments of the identified compounds are needed to address the risks associated with potential exposures to the substances identified as E/L from pharmaceutical packaging or process equipment.

This on-demand webinar will provide an overview of best practices for designing and conducting E/L studies for pharmaceuticals and performing toxicological evaluations of E/L data, including considerations of relevant guidelines and case study examples.  

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