We quantify the risks associated with leachable impurities from container closure systems, process equipment, and medical devices used in packaging human drugs. Our comprehensive extractables and leachables testing ensures the safety and compliance of your products.

Our extractables and leachables (E&L) testing identifies and quantifies harmful leachables from pharmaceutical container closure systems, ensuring product safety and compliance. Our E&L studies, including controlled extractables studies (CES), detect potential leachables such as antioxidants, plasticizers, dyes, and metal catalysts.

We provide tailored testing programs for various materials, including plastic, rubber, glass, and coatings, adhering to evolving regulatory requirements. Our expert team uses advanced analytical techniques like LC-MS/MS, GC-MS/MS, and ICPMS to identify organic and inorganic contaminants.