Extractables and Leachables Testing for Transdermal Applications: Challenges and Considerations

Drug products vary in their physical form, dosage and application. Therefore, every type of drug product should be presented in the right packaging and delivery system during product design and production. All the different packaging and/or delivery systems pose their own challenges when it comes to extractables and leachables testing. Specifically for transdermal products, the main challenge during extractables and leachables testing is to obtain a representative sample and sample blank that are compatible with sensitive chromatographic mass-spec techniques. In this presentation, these challenges and their implications on extractables and leachables study design are addressed for different kinds of transdermal drug products.