Extractables And Leachables Solutions

Assessing Extractable and Leachable (E&L) substances in finished drug products and their packaging is critical for minimizing patient safety risks linked to harmful interactions with contact materials. E&L compounds can introduce potential contaminants into the final product, affecting not only its efficacy but also its color, taste, odor, and pH. In some cases, they may inactivate the active pharmaceutical ingredient or increase the drug’s carcinogenic potential.

E&L studies are therefore an essential step in ensuring the safe release of a drug for human use. These assessments help identify impurities that may migrate from packaging and manufacturing surfaces into the final product during production, storage, or transport.

Conducting E&L studies is a multifaceted and highly specialized process. At Aragen, we offer a comprehensive Extractable and Leachable testing program aligned with global regulatory guidelines. Studies can follow standard protocols or be customized to meet specific client requirements. Leveraging world-class analytical infrastructure, our experts design study protocols, develop and validate methods, and conduct stability testing — providing the insights needed to ensure product safety and support a successful market launch.