Extractables & Leachables (E&L) Studies
Extractables and leachables studies help identify and evaluate chemical substances that may be released from packaging, container-closure systems, manufacturing components or medical devices into a pharmaceutical product. DALPL offers E&L services spanning extractables profiling, leachables screening, analytical chemistry, elemental impurities and related method development and evaluation.
Understanding Extractables & Leachables
Material-to-product interactions represent an essential quality and safety consideration for modern drug development and packaging qualification.
What Are Extractables?
Extractables are substances that can be drawn out of a material under defined extraction conditions. Extractables studies help characterise the chemical profile of materials used in pharmaceutical packaging, manufacturing systems and related product-contact components.
What Are Leachables?
Leachables are substances that migrate from packaging or product-contact materials into a drug product under actual or simulated conditions of use. Their presence and levels may need to be assessed in the context of product quality and patient safety.
Why Do E&L Studies Matter?
E&L studies help pharmaceutical teams:
Materials and Systems Covered
Testing support tailored to relevant contact materials, manufacturing components and delivery systems.
Container Materials & Packaging
Assessment of materials and packaging components that may contact or contain a pharmaceutical product.
Single-Use Systems (SUS)
E&L testing support for applicable single-use systems used in pharmaceutical manufacturing.
Medical Devices
Testing support for relevant medical devices and product-contact components.
Material and component suitability should be assessed on a project-by-project basis. Specific polymer, elastomer or packaging formats are determined based on study protocol and product requirements.
Extractables & Leachables Services
DALPL's brochure describes a service offering across analytical characterisation, extractables profiling, leachables assessment and related technical support. Applicable services and study design should be confirmed for each project.
Extractables Profiling
Planned extraction and analytical characterisation to identify substances that may be extracted from relevant materials under defined study conditions.
Leachables Screening
Screening to investigate substances that may migrate from product-contact materials into a pharmaceutical product or study medium.
Simulation Studies
Simulation studies to help evaluate potential material-to-product interactions under selected study conditions.
Analytical Chemistry & Chemical Characterisation
Analytical work to characterise detected compounds and support interpretation of the chemical profile.
Elemental Impurities
Elemental analysis as part of an applicable E&L assessment where relevant to the materials and study objectives.
Method Development & Validation
Development and validation of analytical methods for target leachables or other defined study requirements, subject to project scope.
Migration Studies
Evaluation of potential migration from relevant materials or systems under defined study conditions.
Medical Device Testing
E&L-related testing for applicable medical-device materials and product-contact components.
Consultancy & E&L Strategy
Support in planning E&L strategies and considering appropriate materials, study stages and analytical needs.
Root-Cause Evaluation
Analytical investigation to help evaluate potential sources of detected substances or unexpected findings, where within the agreed project scope.
Analytical Techniques
The brochure identifies analytical approaches for volatile, semi-volatile and non-volatile organic compounds, along with elemental impurities.
Volatile Organic Compounds (VOCs)
Targeted screening and quantification for low boiling-point organic substances and solvent migrants.
Semi-Volatile Organic Compounds
Comprehensive profiling for additives, plasticisers, slip agents and related organic compounds.
Non-Volatile Organic Compounds
High-resolution characterisation of polar, high molecular-weight compounds and oligomers.
Elemental Impurities
Ultra-trace detection and measurement of inorganic catalysts, heavy metals and elemental migrants.
A Structured E&L Assessment Process
The brochure presents the assessment as a sequence from project preparation and risk assessment through extractables and leachables studies.
Project Preparation
- Collect relevant information from suppliers and material sources.
- Review material compatibility information and available certificates.
- Assess supply-chain information, including potential changes or modifications.
- Rank, prioritise and bracket materials as appropriate to the project.
Risk Assessment
- Evaluate the overall process and potential interaction risks.
- Select materials and define the study approach.
- Develop the project protocol and milestones.
Extractables Study
- Execute the agreed extractables protocol.
- Identify and evaluate extractables.
- Generate the study report.
- Use findings to inform preliminary leachables considerations and toxicological assessment.
Leachables Study
- Conduct relevant method development and validation.
- Perform screening and product-specific evaluation as defined by the study plan.
- Evaluate leachables findings and prepare the report.
- Consider final risk assessment, change control and risk-control strategies.
E&L Across the Product Lifecycle
E&L considerations can begin during early product and material selection and continue through development, packaging qualification, process changes and commercial manufacture. Early planning can help teams identify material-related risks and determine where additional extractables, simulation or leachables work may be appropriate.
Early Development
Identify relevant product-contact materials and assess potential interaction risks.
Formulation & Process Development
Use material and study information to plan appropriate evaluation.
Late Development & Qualification
Evaluate packaging and process-related questions relevant to the product.
Commercial Lifecycle
Consider E&L implications when applicable materials, packaging or manufacturing systems change.
Why Work with DALPL?
E&L projects bring together material knowledge, analytical chemistry, study design and interpretation. DALPL's brochure describes services intended to support pharmaceutical teams through relevant analytical testing and reporting.
Multiple Analytical Areas
Services described across organic compounds and elemental impurities.
Study Planning Support
E&L strategy and consultancy options to help define the project scope.
Lifecycle Perspective
A process that considers project preparation, risk assessment, extractables and leachables evaluation.
Analytical Reporting
Study reporting as part of the agreed project deliverables.
Frequently Asked Questions
Key questions regarding DALPL's extractables and leachables testing services.
Related Pharmaceutical Testing Services
Explore DALPL's specialised testing services across trace analysis, formulation characterisation and bioequivalence.
Discuss Your Extractables & Leachables Requirements
Tell us about your product, packaging or product-contact materials and the E&L question you need to address. DALPL can discuss relevant analytical services and potential study scope with your team.