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Ensure Safety, Compliance, and Product Integrity with Expert E&L Testing

During drug and medical device development, chemicals from various sources like packaging, manufacturing components, or delivery systems can migrate into products posing risks to patient safety and product quality. Extractable & Leachable (E&L) testing identifies these risks ensuring compliance with global regulations and safeguarding your brand reputation.

Why E&L Testing Matters

Regulatory agencies (FDA, EMA, etc.) mandate E&L studies to:

  • Protect patients from toxic leachables in pharmaceuticals, biologics, or medical devices.
  • Prevent product adulteration caused by chemical interactions.
  • Validate material safety in container closure systems, single-use bioprocess components, and medical devices

Comprehensive E&L Services for Pharmaceuticals and Medical devices

We support:

  • Pharmaceutical drug products & biologics
  • Medical device chemical characterization (ISO 10993)
  • Container closure systems (USP <1663>, <1664>)
  • Label migration studies
  • Single-use manufacturing components (BPOG, BPSA)
  • Toxicological risk assessments

Why Partner with Eurofins?

  • Tailored Study Design: Custom protocols aligned with USP, ISO, PQRI, and BPOG guidelines.
  • Regulatory Expertise: Compliance with FDA CDER/CBER/CDRH, EMA, and global standards.
  • Sophisticated Analytical Capabilities: State-of-the-art LC/MS/MS, GC/MS/MS, ICP/MS, and IC instrumentation.
  • End-to-End Support: From risk assessment and GMP-compliant protocols to stability studies and toxicological evaluations.
  • Actionable Reporting: Detailed results with chromatograms, system suitability data, and clear toxicological insights.

Our Methodologies

Extraction Techniques:

  • Reflux, Soxhlet, sonication, microwave, and controlled-temperature incubation.

Analytical Techniques:

  • Organic Compounds: Semi-quantitative screening via GC/MS, LC/MS/MS, and LC/UV.
  • Metals & Ions: ICP/MS (USP <232>, ICH Q3D) and ion chromatography.
  • Gravimetric Analysis: Quantifying total extractables.

Cutting-Edge Instrumentation

  • Shimadzu LC/MS/MS 8060 & 8045
  • Shimadzu GC/MS/MS (headspace/direct injection)
  • PerkinElmer ICP/MS
  • Thermo Scientific IC-6000
  • Waters HPLC (UV/Vis, PDA)
  • Agilent’s Gradient Q-TOF

FAQs: Your E&L Testing Questions Answered

1. What’s the difference between extractables and leachables?
Extractables are compounds that can be forcibly extracted from a material (such as packaging, medical devices, or container closures) under aggressive laboratory conditions (e.g., using solvents, heat, or extreme pH) while leachables actually migrate into drug products under normal storage and use conditions over time. Both require evaluation to assess patient risk.

2. Why is E&L testing critical for regulatory approval?
Regulators demand proof that products are free from harmful leachables. Non-compliance risks delays, recalls, or rejection. Our studies meet FDA, EMA, and ISO standards to facilitate approvals.

3. How does Eurofins ensure global regulatory compliance?
Our protocols align with USP, ISO 10993, BPOG, and ICH guidelines. We design studies to meet the requirements of FDA, EMA, and other agencies, with documentation ready for submission.

4. Can Eurofins assess toxicological risks?
Yes. Our experts evaluate detected compounds against ICH Q3D, ISO 10993-17, and other frameworks, providing safety thresholds (e.g., AET, SCT) to guide risk mitigation.

5. What industries do you serve?
Pharmaceuticals and medical devices. We specialize in container closure systems, single-use technologies, and label migration studies.

Partner with Confidence
Protect your products and patients with Eurofins BioPharma Product Testing India. Let us help you navigate E&L challenges with precision and compliance.

Eurofins BioPharma Product Testing India – Where Precision Meets Compliance.