Conference Talk | Screening & Control of Extractables & Leachables – An Analytical Approach

Keynote Presentation | 3rd Annual Extractables & Leachables Conference
Berlin, Germany, Dec 1-2 2022 

Polymer materials, printing inks and adhesives are often in contact with pharmaceutical formulations during production and final storage. These typically contain a high number of additives and other functional small molecules used to tailor and retain the product properties. Unfortunately, these small molecules are easily leached out by pharmaceutical formulations and residues of leachable compounds and their degradation products are frequently observed as contamination in API and final formulations. Some leachables are known to be mutagenic and many of them pose at least a certain reactivity and so could cause adverse effects on the human body even if only present at trace level concentrations.

The detection, quantitation, and evaluation of such molecules is important but could be  challenging since matrix effects often discriminate the compounds of interest. During the 3rd Annual Extractables & Leachables Conference, we present on an appropriate stepwise study design to help overcome such issues. This study design should yield data which will allow estimation of the toxicological risk for the patient. In our presentation, we focus on compendial guidelines for E&L studies, highlight the analytical challenges and propose possible solutions to these challenges:

• Sources for known and unknown leachables
• General screening - choosing the right techniques
• Reasonable analytical control strategy
• Structure elucidation and quantification of leachables in complex matrices
• Validation and routine monitoring