Determination of Extractable Semi – Volatile Organic Compounds by GC/MS

Gas Chromatography–Mass Spectrometry (GC/MS) is a powerful analytical technique used to detect and semi-quantify extractable semi-volatile organic compounds (SVOCs) from medical device materials. This method helps identify potentially harmful substances such as plasticizers, residual solvents, and degradation products that may leach from devices under simulated use conditions. GC/MS is typically used in combination with other orthogonal methods to provide a comprehensive chemical profile. It plays a critical role in chemical characterization, supporting toxicological risk assessments and regulatory submissions by ensuring that devices meet safety standards for patient exposure.

Why This Testing is Performed

GC/MS testing is performed to identify and evaluate SVOCs that may migrate from medical devices during use. These compounds can pose toxicological risks if not properly assessed. The test supports biocompatibility evaluations and helps manufacturers demonstrate that their products are safe for clinical application. It is essential for meeting regulatory expectations and for guiding material selection and manufacturing processes.

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Steps in Conducting This Test

1. Sample Preparation: Device materials are extracted using solvents under controlled conditions.
2. Standard Preparation: Known compounds are prepared to validate system performance and support semi-quantification.
3. Injection: Extracts are injected into the GC/MS system.
4. Separation: Compounds are separated in the gas chromatograph based on volatility and polarity.
5. Detection: Mass spectrometry identifies compounds by their mass-to-charge ratio.
6. Quantification: Concentrations are estimated using external standards.
7. Data Interpretation: Results are compared to toxicological thresholds and used in risk assessments.

Standards, Guidance, and Regulations

• ISO 10993-18:2020: Provides requirements for chemical characterization of medical device materials.
• FDA Guidance: Recommends method qualification and verification for extract manipulation procedures.
• EPA Method 8270E: Offers procedures for SVOC analysis using GC/MS.