Setting Thresholds in Extractables and Leachables Studies

Synopsis

Extractable and Leachables studies will show an ever expanding number of organic and inorganic species migrating from the pharmaceutical packaging. In all the potential techniques used to provide either an extractables or leachables profile, the question that need to be addressed in the limit one must investigate to measure and understand the risk the packaging poses on the pharmaceutical product.  Applying an appropriate safety concern threshold and calculating an analytical evaluation threshold is vital in producing a scientifically robust study. It is therefore important to understand what safety concern threshold should be used, how best to calculate the analytical evaluation threshold and what other factors should be taken into consideration.