Extractables and Leachables Testing performed by Neotron

Extractables and leachables (E&L) testing is a critical component in the pharmaceutical industry, ensuring the safety and efficacy of drug products. Extractables are chemical compounds that can be extracted from any product contact material when exposed to an appropriate solvent under specific conditions. Leachables are compounds that could migrate from packaging or manufacturing components into the drug product during its shelf life or patient use.

Neotron's Expertise in E&L Testing

With extensive experience in packaging evaluation and analysis, Neotron offers comprehensive E&L studies tailored to client needs within both ISO and GMP environments. Our services include:

• Extractable Studies: Controlled extractions of materials/components using model solvents to identify potential risks.
• Toxicology Evaluation: Collaboration with toxicologists to evaluate extractables data and identify compounds of toxicological concern.
• Method Optimization: Developing and refining methods to ensure accurate and reliable results.
• Leachables Studies: Conducting leachables testing, including untargeted and targeted analyses, to detect and quantify compounds that migrate into the drug product.

Risk Assessment

We also offer comprehensive risk assessment services, evaluating both primary and secondary packaging as well as all components involved in the final stages of packaging or filling processes.

Analytical Approach for E&L Testing

• Our analytical techniques cover a wide range of potential contaminants:
• Volatile Organic Compounds (VOC): Using HS-GC/MS for precise identification.
• Semi-Volatile Organic Compounds (SVOC): Utilizing GC/MS for accurate detection.
• Non-Volatile Organic Compounds (NVOC): Employing LC-Q-TOF for comprehensive analysis.
• Elemental Impurities: Measuring using ICP-MS and ICP-OES.
• Ion Chromatography

Regulatory Compliance

Neotron ensures compliance with international standards and guidelines, including:

• ICH
• ISO 10993-18
• USP 1663/1664
• USP 665/1665
• BPOG
• PQRI

Study Design and Execution

Our E&L study design includes:

• Preliminary Compatibility Solvent Study: Assessing initial solvent compatibility.
• Extractables Testing: Identifying and quantifying extractables.
• Leachables Testing: Detecting leachables in the final product, including targeted analysis for specific concern compounds identified during extractables testing.

Conclusion

Neotron's dedicated departments provide analytical proposals for preliminary compatibility studies, extractables, and leachables testing, ensuring the safety and compliance of pharmaceutical packaging materials. For more information, please contact us.