Practical strategies to decrease uncertainty in comprehensive extractables and leachables analysis by LC/MS

by | Biopharma, Hyphenated Techniques, Pharmaceutical

In extractables studies, LC/UV/MS is commonly used to detect and annotate the non-volatile fraction of compounds.

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Industry guidance and regulatory requirements indicate an analytical evaluation threshold (AET), above which compounds need to be identified to allow for toxicological risk assessment, requiring estimated quantitation before their identity is known. UV and MS detector response is known to vary for analytes, requiring the use of an uncertainty factor to account for difference in response relative to a reference standard at the AET.

In this presentation, we discuss the challenges associated with these analyses and present strategies that can be deployed to reduce uncertainty in LC/MS extractable studies, including the combination of the three detection techniques in one system to allow the concurrent measurement of UV absorption, CAD signal, and high resolution-accurate mass (HRAM) mass spectra from one injection.

By viewing this presentation you will learn about:

  • Ways to decrease analytical uncertainty in quantitation of unknown extractables by LC/MS
  • How incorporating UV, CAD, and MS in one system provides orthogonal detection based on different properties, increasing compound coverage and annotation confidence
  • How the universal response of the CAD detector, when used with the Vanquish Duo for inverse gradient system, enables semi-quantitation of unknown compounds against surrogate standards with lower uncertainty

The Presenters

Chongming_Liu_100_100Chongming Liu
Chongming Liu is currently a Supervisor in the Extractables and Leachables (E&L) team at SGS Health Science in Fairfield, New Jersey, USA. At SGS, his daily responsibility is to assist the team members in performing E&L testing on pharmaceutical containers and medical devices and to elucidate structures for compounds of interest based on high-resolution GC-FID/MS and LC-PDA/MS data. Prior to that, he joined the E&L team at SGS in 2018 as an Instrumentation Chemist. Chongming holds a PhD degree in Analytical Chemistry from Stevens Institute of Technology, in Hoboken, New Jersey and a BSc degree in Chemistry from the University of Science and Technology of China (USTC), in Hefei, China.


Sven_Hackbusch_100_100Sven Hackbusch
Sven Hackbusch is currently a Senior Application Scientist at Thermo Fisher Scientific, responsible for the development of LC/MS applications related to structural elucidation for and in collaboration with customers in the Pharma/Biopharma markets. He joined Thermo Fisher Scientific in 2017 as an Application Scientist in the LC/MS product demonstration laboratory, focusing on untargeted small molecule applications using Thermo Scientific Orbitrap technology. Sven holds a PhD in Pharmaceutical and Chemical Sciences from the University of the Pacific in Stockton, California, USA and a BSc in Chemistry from the Justus Liebig Universität Gießen in Gießen, Germany.

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Published  May 25, 2023

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