The U.S. Food and Drug Administration (US FDA), the European Medicines Agency (EMA) and other regulatory agencies have set guidelines which require extractable and leachable information to be included for container closure systems and medical devices. Learn about a faster and accurate method using accelerated solvent extraction coupled with high resolution accurate mass (HR/AM) mass spectrometry for the analysis of unknown extractables.

In this webcast you will learn the understanding and importance of extractables studies, as well as the fundamentals of accelerated solvent extraction (ASE). We will discuss the comparison of speed and efficiency of ASE versus soxhlet.

This webcast is aimed at analytical scientists/chemists developing methods for extractable and leachable studies, pharmaceutical and biopharmaceutical lab mangers responsible for technology adoption and lab efficiency programs, and regulatory specialists interested in the effects of biocompatible and pharmaceutical compatible materials on product quality and safety.

Topics include:

• Regulatory background and importance of extractables studies
• Fundamentals of accelerated solvent extraction (ASE)
• Comparison ofthe speed and efficiency of ASE versus soxhlet in extractable studies