Extractables & Leachables Standards
Reference Standards for E&L Studies in Pharmaceutical Development and Quality Control
Extractables & Leachables (E&L) play a crucial role in assessing the product safety of drugs, biopharmaceuticals, and medical devices. Eurofins offers a broad portfolio of Extractables & Leachables reference standards to support the identification, quantification, and risk assessment of potentially migrating substances.
Our standards are used worldwide in E&L studies, method validations, and regulatory investigations, supporting compliance with current requirements from FDA, EMA, USP, and ICH.
What are Extractables & Leachables?
Extractables are chemical compounds that can be released from packaging materials, closure systems, single-use components, or manufacturing equipment under aggressive extraction conditions.
Leachables are substances that actually migrate into the drug product or biopharmaceutical under normal storage and use conditions.
The study of these substances is an essential part of product development to identify and minimize potential risks to patients.
Why are E&L studies important?
Extractables and Leachables analyses help to:
- Ensure patient safety
- Identify migration risks early
- Fulfill regulatory requirements
- Qualify packaging systems
- Evaluate single-use technologies
- Safeguard biopharmaceutical processes
- Support regulatory submissions
Our Portfolio of Extractables & Leachables Standards
Packaging-Related Impurities
Reference standards for potentially migrating substances from:
- Plastic packaging
- Elastomers and stoppers
- Closure systems
- Primary packaging
- Coatings and seals
Additives & Excipients
Standards for frequently studied substance groups such as:
- Antioxidants
- Plasticizers
- Stabilizers
- UV absorbers
- Lubricants
- Processing aids
Polymer Degradation Products
Reference materials for compounds that can arise from aging or stress of plastics.
Single-Use System Standards
Standards to support E&L investigations in:
- Bioreactors
- Filtration systems
- Tubing
- Bag systems
- Single-use components
Areas of Application
Our E&L reference standards are used for:
- Extractables studies
- Leachables studies
- Packaging Qualification
- Container Closure Integrity Programs
- Single-Use System Evaluations
- Method Development
- Method Validation
- Risk Analyses
- GMP-compliant Quality Control
Analytical Methods
Extractables & Leachables Standards support, among others:
- GC-MS
- LC-MS/MS
- UHPLC
- HPLC
- ICP-MS
- Headspace-GC
- Screening and Target Analyses
Why Eurofins?
Extensive Product Selection
Access to a variety of relevant E&L reference standards for pharmaceutical and biopharmaceutical applications.
Regulatory Expertise
Support for studies in line with international requirements and industry standards.
Quickly Available
Efficient supply chains and reliable sourcing for routine and project needs.
Partner for Product Safety
Eurofins supports pharmaceutical, biotech, and medical device companies worldwide in assessing potential migration risks.
Frequently Asked Questions
What is the difference between Extractables and Leachables?
Extractables are released from materials under forced extraction conditions. Leachables are substances that actually migrate into the product during storage or use.
What materials are typically examined?
Plastics, elastomers, closure systems, packaging, tubing, filters, and other product-contacting components.
Which industries use E&L standards?
Pharmaceutical industry, biopharmaceutical industry, medical technology, packaging manufacturers, and contract laboratories.
Why are reference standards needed?
They enable the clear identification and reliable quantification of potential leachables and extractables in analytical methods.
Find the Right Extractables & Leachables Standards
Whether packaging materials, single-use systems, or product-contacting components: Eurofins offers high-quality reference standards to support your E&L programs and regulatory requirements.
Your Advantages at a Glance
✅ Standards for Extractables and Leachables studies
✅ Support for GC-MS, LC-MS/MS, and ICP-MS methods
✅ Solutions for Pharma, Biotech, and Medical Devices
✅ Support regulatory compliance
✅ Fast delivery and expert advice
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