White Paper | From Extractables to Leachables: Problem Solving for Complicated Formulations and Container Closure Systems


The purpose of an extractables and leachables investigation is to help ensure that a pharmaceutical packaging container closure system (CCS) is safe, and does not negatively influence the drug product. But, navigating the complexities of an E&L study can be daunting, and there are many potential challenges that may arise along the way.

Our white paper, authored by Dr. Tino Otte, Head of Sales and Consulting at Intertek, covers all aspects of the E&L study, from the analysis of volatiles, semi-volatiles, and nonvolatiles, to the identification of typical challenges at each step of the study and the deployment of the most suitable approaches to overcome any barriers to a successful study.

Download our white paper now and learn how to anticipate potential issues and put the most effective solutions into play.