Analysis of Extractables and Leachablesin Catheters Using Accurate Mass Libraries and High-Resolution GC/MS and LC/MS

Importance of the Topic

Extractables and leachables analysis is critical for evaluating the safety and performance of medical devices by detecting compounds that migrate from device materials into biological systems.

Objectives and Study Overview

This study aimed to develop a robust analytical workflow for comprehensive characterization of extractables and leachables in catheter materials using high-resolution GC/Q-TOF and LC/Q-TOF platforms.

Methodology

Catheter samples from three suppliers were extracted in ethanol:water (1:1) at 37 °C for 24 h, 48 h and 7 days. GC/Q-TOF analysis was performed with electron ionization at 70 eV on an Agilent 8890 GC with a DB-5Q column. LC/Q-TOF analysis employed electrospray ionization on an Agilent 1290 Infinity II system with a PS AQ-C18 column using a water/methanol gradient with ammonium formate and formic acid additives. Data processing combined untargeted deconvolution, suspect screening and library matching against accurate mass E&L and NIST spectral databases.

Used Instrumentation

• Agilent 8890 GC coupled to 7250 GC/Q-TOF with DB-5Q column
• Agilent 1290 Infinity II LC coupled to Revident LC/Q-TOF with PS AQ-C18 column
• MassHunter Quantitative Analysis, Explorer and MassProfiler Professional software for data processing and statistical analysis

Main Results and Discussion

An accurate mass E&L library with over 400 compounds was created, including annotated fragment formulas from EI spectra. GC/Q-TOF suspect screening detected plasticizers, phthalates, antioxidants, UV absorbers and nitrosamines in catheter extracts. Non-targeted workflows differentiated material types and revealed distinct extractable profiles. LC/Q-TOF analysis provided complementary detection of polar and sulfur-containing leachables. Principal component analysis highlighted clear clustering by catheter formulation.

Benefits and Practical Applications

The combined high-resolution GC and LC workflow delivers broad chemical coverage and high confidence in compound identification. It streamlines quality control and regulatory compliance by reducing manual review and accelerating E&L risk assessments in medical device manufacturing.

Future Trends and Applications

Integration of machine learning for automated spectral deconvolution, expansion of high-resolution libraries and real-time monitoring strategies will enhance throughput and sensitivity. Closer linkage with regulatory databases and in silico tools will further optimize E&L evaluation for novel polymer materials.

Conclusion

A unified GC/Q-TOF and LC/Q-TOF analytical workflow using accurate mass libraries effectively characterized extractables and leachables in catheter samples, demonstrating comprehensive analyte coverage and reliable material differentiation for medical device safety assessment.