Non-Targeted Identification of Extractables and Leachables from Medical Device Polymers Using ESI and SICRIT-LC/QTOF with LabSolutions Insight Profiler

User Benefits

- Application of a single processing method with a novel software application LabSolutions Insight Profiler, to identify extractable and leachable (E&L) compounds in medical polymer materials extracted in water or isopropanol. - The screening workflow enabled detection of E&L compounds in foam extracts that were not detected in representative blanks. - Application of SICRIT ion source extended the chemical search space for the LC-DIA-MS/MS method, enabling detection of additional E&L compounds that were not detected using ESI.

Introduction

Extractables and leachables (E&L) from medical device polymers may present toxicological risks during clinical use. Regulatory frameworks such as ISO 10993 require chemical characterisation to ensure patient safety. ISO 10993-18, part of the ISO 10993 series for the biological evaluation of medical devices, provides a framework for the chemical characterisation of materials to identify substances that could leach from a device during clinical use. Within this regulatory framework, the objective is to assess biological risk and potential patient exposure by identifying E&L components in medical devices. This application presents a workflow for the non-targeted analysis of medical foam extracts to identify potential E&L compounds. To highlight the non-targeted screening workflow for E&L, LC/QTOF was applied to the analysis of different polymer materials used in medical devices for sleep apnoea. LC/QTOF data were acquired using TOF MS and data independent acquisition (DIA)-MS/MS with Electrospray Ionization (ESI) and Soft Ionization by Chemical Reaction in Transfer (SICRIT) in positive and negative ion modes. SICRIT was applied to increase chemical space in detecting potential E&L compounds by LC/QTOF through gas-phase ionization, where a stable dielectric barrier discharge ionization (DBDI) plasma promotes multiple concurrent ionization pathways, including proton transfer, radical cation formation, and charge-transfer/photoionization. Both ESI and SICRIT data were processed using LabSolutions Insight Profiler. The application software is designed to help automate feature detection, alignment and compound identification with suspect screening. In this work, compound screening lists included the ELSIE chemical list hosted within EPA’s CompTox Chemicals Dashboard, FDA-CLAP, and NIST 2023. Following this workflow, E&L compounds were identified in the medical foam extracts including hindered amine light stabilisers (HALS), hindered phenolic antioxidants, flame retardants, slip and anti-blocking agents, common plasticisers and surface modifiers, as well as residual surfactant or processing aids.

September 28, 2026 GMT