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Role of Solvent Selection for the Mass Spectrometric Analysis of Medical Devices in Extractables and Leachables (E&L) Testing

The following poster was presented at the Extractables & Leachables session of the annual conference of American Society for Mass Spectrometry (ASMS) in Minneapolis.

Read the following abstract to learn more.

Routine E&L testing of medical devices requires extraction using three solvent systems with differing polarity:  nonpolar (like hexane or DCM), mid-polar (like IPA), and polar (like water), which is usually followed by the mass spectrometry analysis. While GC-MS and LC-APCI-MS are conventionally used to analyze hexane extracts, there is a growing (and specific) demand for the analysis of hexane extracts by LC-ESI-MS. Hexane is considered one of the non-compatible solvents for the ESI due to its highly nonpolar nature. Therefore, we studied evaporation and reconstitution of selected E&L quality control chemical standards from hexane & IPA to different ESI-compatible solvents. Results show the possibility of achieving the desired analysis without losing the method’s analytical sensitivity and selectivity.

The authors employed by Nelson Labs are listed below. The other author is Benjamin Hunt.


Manoj Ghaste

Senior Development Scientist

Manoj Ghaste received his Ph.D. in Bioanalytical Chemistry and Metabolomics (2015) from the Centre of the Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Italy. He joined Nelson Labs, Salt Lake City in 2021 as a Senior Development Scientist in Analytical Chemistry Department. Prior to coming to Nelson Labs, he worked as Postdoctoral Fellow at Purdue University & University of North Texas. During his career, over the last 14 years, he has worked extensively in the field of development and applications of advanced mass spectrometry platforms for different types of chemical analyses, and published 13 peer-reviewed publications with over 600 citations. In addition, he is an active member of several professional organizations, such as the Royal Society of Chemistry (MRSC), the American Society for Mass Spectrometry (ASMS), the Association of Official Analytical Chemists (AOAC International), and the Metabolomics Association of North America (MANA).

Kimberly Mitchell

Lab Analyst II

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