By West Pharmaceutical
Published in: Pharmaceutical OnLine
Published on:
Many types of packaging materials are involved in the production and containment of drug products, such as the elastomeric closure, vials, or another containment device. Each of these items may impact the drug product over time. The typical process of evaluating E&L begins with identifying the extractables, which are chemical compounds that can be released from containers, closures, and packaging materials under exaggerated or extreme conditions. While extractable testing is a necessary starting point, it does not provide all the required information to determine drug compatibility. Therefore, further testing is needed to investigate leachables, which are the subset of extractables that migrate into the drug product under normal conditions. In an ideal situation, the only leachable compounds detected in a drug are compounds present in the extractables profile, however, the leachable profile can contain additional compounds. These additional leachables can be the result of environmental influences or reactions between compounds and the drug, generating new compounds not previously detected.
