Dr. Weixi Liu presents an alternative strategy for extractables and leachables analysis using a multidetector strategy with LC-MS, GC-MS, ultraviolet and charged aerosol detection and flame ionization detection.

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Chemical characterization per ISO 10993, and <1664> has become an important component of testing of medical devices and drug products. A major concern regarding the accuracy of extractables and leachables studies is quantitative error due to response factor (RF) variation. Recent publications have highlighted the risks posed by RF variation for both LCMS (Jordi et al. Journal of Pharmaceutical and Biomedical Analysis 150 (2018) 368–376) and GCMS (Jenke and Odufu, Journal of Chromatographic Science 2012;50:206–212). The importance of this issue has been recognized by the FDA resulting in the addition of an uncertainty factor (UF) in the calculation of the analytical evaluation threshold (AET).

In this presentation, an alternative strategy for quantitation using a multidetector strategy including a liquid chromatography system with mass spectroscopy (LCMS), ultraviolet (UV) and charged aerosol detection (CAD) as well as a Gas Chromatography system using mass spectroscopy (MS) and Flame Ionization Detection (FID) is presented. Data comparing the response factors for more than 200 extractables is presented demonstrating an approach to reduce overall RF variation, reducing the associated need for UFs and increasing confidence in the resulting risk assessments.

Key Topics Include:

  • Learn how the Multidetector Strategy addresses the problem of underreporting at the Analytical Evaluation Threshold (AET)
  • Understand why the Multidetector Strategy provides for improved quantitative accuracy
  • Understand the advantages and limitations of Response Factor (RF) databases

Resources

#ExpertAnswers: Weixi Liu on Extractables and Leachables Analysis

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Presenters

Weixi Liu, ;PhD

Weixi Liu, PhD

Senior Chemist II/Study Director
Jordi Labs

Dr. Liu has been a Study Director at Jordi Labs since 2017. Dr. Liu’s role at Jordi Labs includes the development of improved strategies for identification and quantification of Extractables and Leachables. Prior to that, Dr. Liu completed her postdoctoral research at University of Rhode Island, School of Pharmacy with research focusing on protein glycation. Dr. Liu authored or co-authored more than 20 publications and serves as reviewer and guest editor for leading journals in the area of analytical chemistry. She was invited multiple times to give presentations at national meetings on analytical method development and optimization with a focus on mass spectrometry. Dr. Liu holds a Ph.D. in Chemistry from University of Rhode Island and a B.S. in Pharmaceutical Sciences from China Pharmaceutical University. Dr. Liu is a member of ACS, ASBMB and ASMS.
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