Extractable and leachable (E&L) testing quantifies the risks associated with finished pharmaceutical product containers, bioprocess manufacturing systems, and medical devices. Extractable and leachables studies are designed to be optimized and customized for the pharmaceutical container or closure under investigation, such as materials and their compatibility with extraction solvents, type of container, type of contact between the container and the medicinal product, storage conditions, specific administration or reconstitution procedures, type of medicinal product, route of administration, dosing regimen, and associated threshold requirements. Identification and quantification of potentially harmful leachable impurities is critical as these could migrate from pharmaceutical container closure systems to contaminate a pharmaceutical product and so pose a risk to a patient’s health and cause significant quality issues.