HPLC analyses for the characterization of non-volatile organic compounds (NVOC).

HPLC Chemical Characterization – Compliant and Precise

GBA Medical Device Services, a part of GBA Group, is excited to announce the expansion of its service portfolio to include high-performance liquid chromatography (HPLC) analyses for the characterization of non-volatile organic compounds (NVOC).

Why It Matters:

Chemical characterization under ISO 10993-18:2020 + Amd 1:2022 is essential for ensuring regulatory compliance and market readiness of medical devices. With over 25 years of experience using gas chromatography (GC) and headspace-gas chromatography (HS-GC) for toxicological evaluations, GBA now adds HPLC analyses to deliver even greater precision in identifying non-volatile extractables and leachables.

Our Expertise Includes:

• Full compliance with ISO 10993-18 and accreditation under ISO/IEC 17025.
• Advanced LC-MS technologies for NVOC analysis, aligned with the latest FDA guidance.
• High-resolution non-targeted analyses using LC-QTOF-MS with broad detection ranges and comprehensive identification capabilities.
• Rapid turnaround times: reliable results in just 6–8 weeks.

This service expansion reinforces our commitment to helping clients achieve regulatory success with innovative, compliant, and precise testing solutions.