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.