Extractables and leachables (E&L) analysis is an area of growing regulatory significance. It poses a series of challenges to the development of ENDS products.
E&L concerns compounds that can migrate into a product from various containers and materials used to deliver nicotine. These migrating compounds can potentially harm the end-user, so regulation is in place to ensure that doesn’t happen.
Studies begin with a risk assessment to ascertain whether there are any materials that need to be qualified. From here, testing commences across single or multiple stages involving testing on extractables, and/or leachables.