Dr. Jianwei Li
Principal E&L and Chemical Characterization Consultant and Technical Writer
Chemical Characterization Solutions LLC
Dr. Jianwei Li is currently the principal E&L and chemical characterization consultant, and chemistry writer at Chemical Characterization Solutions LLC. He worked at Medtronic for nearly 17 years as a technical fellow and subject matter expert in the chemical characterization of medical devices. Over the course of his nearly 30-year academic and industry career, he has published extensively in the area of analytical chemistry with nearly 50 publications, eight of which were devoted to the chemical characterization of medical devices over the last three years. He also served as frequent scientific reviewers for over ten international journals.
He received his PhD in analytical chemistry from Purdue University, and did his postdoctoral research @ University of Minnesota.
DAY 1: MARCH 7th, 2024
SESSION: The current state and analytical challenges with the evaluation of E&L in pharmaceutical and medical device industries
◆ The safety and analytical science expectations of E&L from the perspective of a quantitative “global” space of extractables and leachables in volatility, hydrophobicity, and molecular weight.
◆ A critical review of the current state of analytical testing strategies, including uncertainty on E&L testing.
◆ A critical overview of the major analytical challenges in solvent choice, sample treatment, mass balance, method sensitivity, response factor, accuracy of quantitation and identification, etc, with specific examples.
◆ Tips for choosing an analytical partner.
