Extractable and Leachable (E&L) Services
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What Are Extractables and Leachables?
Extractable and Leachable (E&L) testing is critical for ensuring the safety of pharmaceutical products, packaging, and medical devices. Extractables are compounds that can be extracted from a material under extreme conditions, while leachables are those compounds that migrate into the product under normal usage conditions. At ResolveMass Laboratories, we offer comprehensive E&L testing to ensure regulatory compliance and safeguard patient health.
Why Choose ResolveMass for E&L Analysis?
Our E&L Testing Services
Material Extractables
TestingLeachables
TestingRisk Assessment and Toxicological Evaluation
Simulated Use Testing
Identifying and quantifying extractables using accelerated extraction conditions.
Quantifying leachables under real-world conditions in pharmaceutical products.
Assessing potential health risks of leachables with toxicological evaluations.
Simulating actual product use to ensure long-term safety.
Reliable Extractable and Leachable Testing Services
Ensure product safety and regulatory compliance with our state-of-the-art E&L analysis services.
What Are Extractables and Leachables?
Extractable and Leachable (E&L) testing is critical for ensuring the safety of pharmaceutical products, packaging, and medical devices. Extractables are compounds that can be extracted from a material under extreme conditions, while leachables are those compounds that migrate into the product under normal usage conditions. At ResolveMass Laboratories, we offer comprehensive E&L testing to ensure regulatory compliance and safeguard patient health.
Why Choose ResolveMass for E&L Analysis?
- Expertise: Over a decade of experience in mass spectrometry and analytical chemistry.
- Advanced Equipment: High-resolution LC-MS, GC-MS, and ICP-MS for accurate identification and quantification
- Regulatory Compliance: Services aligned with FDA, EMA, and ISO standards.
- Customized Solutions: Tailored testing protocols for specific materials and products
Our E&L Testing Services
- Material Extractables Testing
- Leachables Testing
- Risk Assessment and Toxicological Evaluation
- Simulated Use Testing
- Identifying and quantifying extractables using accelerated extraction conditions.
- Quantifying leachables under real-world conditions in pharmaceutical products.
- Assessing potential health risks of leachables with toxicological evaluations.
- Simulating actual product use to ensure long-term safety.
Workflow and Methodology
Initial Consultation: Understand client requirements and regulatory guidelines.
Sample Preparation: Customized extraction and leaching procedures.
Analytical Testing: LC-MS, GC-MS, and ICP-MS for detailed analysis.
Data Interpretation: Comprehensive reports with identification, quantification, and safety assessment.
Regulatory Support: Guidance for FDA and EMA submissions.
Equipment and Technology
Regulatory Compliance
Our E&L testing is conducted according to:
- USP <661>, <1663>, <1664>.
- ISO 10993 for medical devices.
- ICH Q3D for pharmaceutical products.
“ResolveMass Laboratories provided exceptional E&L testing services that helped us achieve FDA approval. Their expertise in mass spectrometry is unmatched.”
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