Many regulatory authorities require the routine monitoring
of extractables from polymeric drug delivery device components. Extractables are defined as compounds that can be extracted from polymeric drug delivery device
components using a strong solvent. Routine extractables testing is performed on device components to control leachables within the final product. Leachables are compounds extracted from polymeric drug delivery device components by and into the drug product during the shelf life of the device. Leachables can present safety concerns and may influence the effectiveness of the drug product.
United States
