EXTRACTABLES & LEACHABLES (E&L) STUDIES
Extractables and leachables (E&L) studies evaluate chemical compounds that may migrate from materials, components, or packaging into contacting fluids such as biological media, pharmaceuticals, drug products, beverages, nutraceuticals, or environmental systems. Extractables are compounds released under exaggerated or aggressive conditions, while leachables represent substances that migrate under actual or simulated use conditions. E&L testing is critical for assessing biocompatibility, patient safety, product stability, and regulatory compliance, particularly for medical devices, combination products, pharmaceutical packaging, food-contact materials, and consumer goods.
At Materials Metric, extractables and leachables studies are conducted using a risk-based, scientifically defensible approach supported by a comprehensive analytical platform that includes GC–MS, LC–MS, ICP–MS, ICP–OES, and FTIR. Our integrated workflows enable thorough identification, quantification, and toxicological relevance assessment of potential chemical migrants, supporting biological risk assessment, material selection, and FDA, ISO, and global regulatory submissions.
Uses of Extractables & Leachables Studies
E&L analysis is crucial for:
- Identifying chemical species that migrate from materials into biological or pharmaceutical environments
- Ensuring compliance with ISO 10993-18, USP and FDA guidelines
- Supporting risk assessments for medical devices and packaging systems
- Evaluating compatibility of materials with drugs, biologics, or diagnostic fluids
- Understanding degradation, additive leaching, and material–fluid interactions
- Assessing worst-case and real-use scenarios for chemical migration
- Meeting global regulatory requirements for product approval
Applications
E&L studies are essential for:
- Medical devices & implantable
- Combination products
- Pharmaceutical & biologic packaging
- IV bags, tubing, syringes, stoppers, seals
- Food-contact materials and consumer packaging
- Elastomers, polymers, adhesives & coatings
- Diagnostic and laboratory consumables
Sample Analysis Process
1. Study Planning & Method Definition
- Identify intended use and regulatory pathways
- Define extraction conditions (temperature, solvent, time)
- Establish simulated-use leachable scenarios
2. Extraction Procedures
- Aggressive extraction for worst-case extractables
- Simulated-use leaching for realistic conditions
- Solvent, pH, and temperature selection based on material chemistry
3. Analytical Measurement
We use multi-technology identification to capture a complete chemical profile:
- GC–MS for volatile & semi-volatile organics
- LC–MS/UPLC for non-volatile organics, additives, oligomers
- ICP–MS/ICP–OES for elemental leachables (metals, catalysts, residues)
- FTIR for functional group identificatio
- Ion chromatography (optional) for extractable ions
4. Reporting & Toxicological Relevance
- Identification and quantification of extractables/leachables
- Unknown peak analysis (if required)
- Chemical risk assessment alignment (ISO, USP, FDA)
- Actionable recommendations to mitigate or resolve issues
Why Choose Materials Metric for E&L Studies
Materials Metric offers regulatory-grade, comprehensive E&L analysis designed to support stringent safety expectations for medical, pharmaceutical, and packaging applications.
• End-to-End E&L Workflows
From extraction design to final chemical identification, we ensure a complete, defensible analytical process.
• Multi-Technique Analytical Platform
Using GC–MS, LC–MS, ICP–MS, FTIR, and complementary tools, we deliver a full-spectrum chemical profile that many labs cannot achieve.
• Expertise in Medical Device & Packaging Chemistry
We understand polymer chemistry, additive migration, solvent interactions, and biological compatibility—allowing us to provide meaningful interpretation, not just raw data.
• Regulatory Alignment (ISO 10993-18, USP <661>, FDA Guidance)
Our reporting structure meets the expectations of premarket submissions, audits, and safety risk assessments.
• Clear, Actionable Insights
We help clients determine:
- whether a leachable poses a safety concern
- whether extractable compounds come from additives or degradation
- how material selection or processing can be optimized
Materials Metric provides high-fidelity E&L results backed by strong scientific justification and regulatory awareness.