Insights into Practical Issues Associated with Extractables Testing...

Full title: Insights into Practical Issues Associated with Extractables Testing of Medical Devices It is a well-known adage that “the devil is in the details.” As authoritative texts and regulatory guidelines that address the chemical characterization of medical devices usually present concepts and generalities and lack granularity, sponsors seeking to design and implement extraction studies for medical devices occasionally struggle to establish and justify critical experimental details that are scientifically sound, practical, achievable, and regulatorily compliant. This presentation provides insights into several of these critical experimental details, addressing concepts that include: The “It all comes out at Once” Paradox Exhaustive Extractions as a Source of Kinetic Release Data Predicting Exhaustive Extractions with a Minimum Number of Extraction Steps A Rational (?) Approach to Quantitation and Managing the AET Accurate versus Protective Quantitation What exactly is a “Semi-polar” Solvent?