Extractable and leachable (E&L) studies are routinely conducted for products such as medical devices, pharmaceuticals, and packaging for these types of products. The aim of these studies is to make sure that nothing is emitted from the product that can be harmful to the consumer. Harmful compounds can be from the product itself, residuals from manufacturing or from the packaging used for the product.
This document discusses a study using direct thermal extraction to determine leachables from a plastic bottle containing a saline enema solution. Stir Bar Sorptive Extraction (SBSE) was used to quantify the compound of interest in the saline solution.