Extractables & Leachables

Pace® Life Sciences has established a comprehensive and scientifically rigorous approach to extractables and leachables (E&L) testing across a wide range of product types, including pharmaceuticals, biopharmaceuticals, medical devices, and combination products.

Our team designs customized studies to thoroughly identify and quantify extractables — chemical compounds that can be drawn out of container closure systems, device materials, or manufacturing components under exaggerated conditions — as well as leachables, which are compounds that may migrate into the drug product or be delivered to the patient during routine use or under simulated-use conditions.

These studies are critical for assessing potential risks to product quality, safety, and regulatory compliance, ensuring that materials in contact with drug products meet stringent health authority expectations throughout the product lifecycle.