Extractable and Leachable Database Building for High Confidence Identification by Liquid Chromatography-Mass Spectrometry

Introduction

Liquid chromatography-mass spectrometry (LC-MS) is a powerful technique for extractables and leachables (E&L) analysis, capable of identifying and quantifying E&L compounds during medical device testing. These analyses are frequently challenging because of high sample complexity, with a widely diverse set of possible extractables. E&L testing laboratories must be able to identify a range of compounds with high certainty. While the value of subject matter expert data interpretation cannot be understated, a comprehensive mass spectral database that allows for retention time, accurate mass spectrum, and tandem mass spectrum matching is the gold standard for compound identification. It is crucial to add a range of compounds to the database from each compound class frequently observed in E&L studies. The process is iterative, producing an increasingly comprehensive library as more additions are made. Moreover, regularly observed compounds should be procured and added to the library as they are identified.

When preparing a medical device chemical characterization report, Eurofins EAG Laboratories provides confidence levels alongside identifications to give more context to the toxicologist providing the risk assessment. Higher identification confidence yields better outcomes in toxicological risk assessments (TRAs). For compounds with limited data, “tentative” identifications provide class-level information without sufficient data to support a single structure. 

Extractable and Leachable Database

Both “confirmed” and “confident” identifications solve the data for a unique compound, but confirmed IDs provide extra assurance through matching retention time, accurate mass, and tandem mass spectra to EAG’s internal databases. Through database building, EAG provides higher-quality chemical characterization reports with reduced turnaround times to support medical device biocompatibility programs.

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