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A Comparative Study of Electron Spray Ionization (ESI) LC/MS versus Atmospheric Pressure Chemical ionization (APCI) LC/MS on Extracts of Medical Devices.

September 14, 2022

4:00 pm CEST

Philippe Verlinde

In the last few years, the Analytical Chemistry approaches to characterize extracts of Medical Devices – In line with the new ISO 10993-18:2020 Standard – has grown considerably. Biocompatibility assessments, based on (experimental) Chemical Characterization of Medical Devices is now one of the standard approaches for a number of toxicological end points. While there is no strict “official guidance” on the selection and use of analytical methodologies, instrumentation and detection technologies, it is clear that LC/MS is one of the standard techniques that needs to be included in such an evaluation to inspect the extracts for Non-Volatile Organic Compounds. However, there has been an ongoing debate on whether to use ESI or APCI as ionisation technique in LC/MS.

At the moment, Regulatory Authorities are inclined to support ESI based MS as the only detection of choice. While there may be some validity in the selection of ESI for polar and semi-polar extracts, based upon available literature and theoretical considerations, the choice of ESI is harder to justify when analyzing non-polar extracts.

Nelson Labs has a vast experience in using both ESI and APCI in the analysis of material extracts for a wide range of extraction solvents, which allows us to compare the experimental outcome of an ESI analysis with the outcome of an APCI analysis for a broad range of materials extracted with extracts of varying polarity. The outcome of this comparative study will be discussed in this presentation and conclusions on the best scientific approaches going forward, will be given.



Dr. Philippe Verlinde

LC/MS-Expert, Nelson Labs Europe

Dr. Verlinde received his Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2009. He worked as a postdoctoral fellow at the University of Leuven (Bioscience Engineering), conducting research in the field of food technology and analytics. From 2010 to 2013 he joined the Institute for Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre as a scientific support officer and was involved in several research projects in the field of method standardization (CEN, ISO), proficiency testing and regulatory aspects of environmental pollutants and food safety. Due to his background he has gained a strong expertise in analytical chemistry, especially in the field of structural elucidation techniques (NMR, MS), method development and validation, trace analysis by chromatography (GC & LC) hyphenated to mass spectrometry (small molecules). In 2013 he joined Toxikon Europe as an analytical expert and study director at the Pharma Department, focusing on impurity identification projects. Since 2016 he is acting as a senior scientist in the R&D team at Nelson Labs Europe and is involved in automation projects and the development of state-of-the art analytical services related to extractables and leachables studies for the pharmaceutical and medical device industries.