Extractables and Leachables

Pharmaceuticals as are defined in the (German) Drug Law (AMG) can contain unwanted substances (of potential toxicological relevance) from their packaging materials (i.e. containment) or as “carry over” from shared production facilities used for various products.

We assess risks for potential adverse health effects making use of the analytical results for “extractables” and “leachables” and the use instructions (posology) of the pharmaceutical (active ingredient and/or its precursor(s)). To that end we derive a human safe threshold for the toxicological active profiles of “extractables” and “leachables”, i.e. Permitted Daily Exposure PDE. See for further reading [»]