Extractables and Leachables (E&L) Testing Services
Resolian’s dedicated E&L team delivers bespoke study design, unknown compound characterization, and toxicological risk assessment – all aligned to FDA, EMA, ISO 10993, USP <1663>/<1664>, and BPOG/ELSIE best practices. GMP and GLP compliant. FDA and MHRA inspection ready.
E&L expertise from study design to regulatory submission - across pharma, medical devices, and biopharma.
What sets Resolian apart is not just the breadth of our analytical capability – it is the depth of our scientific expertise. Our E&L scientists don’t just run samples; they design studies, identify unknowns, and guide clients through complex regulatory landscapes.
Resolian’s dedicated Extractables and Leachables (E&L) team provide the data to allow assessment of the safety and compatibility of your product with its selected storage and delivery devices, as required by regulators. This analytical data will enable you to profile extractables from the primary packaging or device materials, and target leachables in the final product.
Our E&L studies are designed using risk‑based, product‑specific approaches, aligned with current global guidance and recognised industry best practice.
These include USP <1663> and <1664>, USP <665> and <1665>, ISO 10993, FDA and EMA guidance, ICH Q3D (Elemental Impurities) and alignment to the emerging ICH Q3E framework, together with approaches from PQRI and BPOG/ELSIE.
Resolian delivers tailored E&L solutions supporting products from early development through commercialisation and ongoing lifecycle management, enabling confident, regulator‑ready decision making.
Extractables and leachables (E&L) testing provides vital information concerning the potential for impurities deriving from container closure systems, drug delivery devices and manufacturing processes.
This contamination can present a risk in terms of both patient safety and product efficacy.
GMP & GLP COMPLIANT
FDA and MHRA inspection-ready labs in Fordham and Sandwich, UK
FULL LIFECYCLE SUPPORT
From early-stage screening through method validation, stability, and regulatory submission
BESPOKE STUDY DESIGN
Every study tailored to your product, regulatory target, and timeline – not a generic protocol
Tailored E&L Testing for Pharmaceutical, Medical Device, and Biopharma Products
Resolian offers extensive expertise in assessing extractables and leachables testing, including:
Pharmaceuticals
Pharmaceuticals Resolian provides expert E&L testing for pharmaceutical container closure systems supporting injectable, ophthalmic, topical, and inhaled drug products.
Risk based study designs and advanced analytical capabilities enable confident identification and control of extractables and leachables, supporting patient safety, product quality, and successful regulatory submissions.
Medical Devices
Medical Devices Resolian performs extractables testing on complete medical devices and individual components to support chemical characterisation and biocompatibility assessment.
Studies are designed in accordance with ISO 10993 requirements, supporting material selection, risk assessment, and regulatory compliance.
Biopharmaceuticals
Biopharmaceuticals Resolian delivers comprehensive E&L testing for biopharmaceutical products, including pre filled syringes, transfer systems, and process contact materials.
Our studies support compatibility assessment and effective control of leachables across manufacturing, storage, and drug delivery workflows.
Process-equipment related leachables (PERLs) Testing for Single-Use Systems
Product contact manufacturing components may introduce process equipment‑related leachables (PERLs) that impact the safety, quality, or efficacy.
Resolian designs and executes robust E&L studies for single use systems (SUS), multi use systems (MUS), and container closure systems, providing high quality data to support risk management and informed decision making throughout the product lifecycle.
Consumer Healthcare
Resolian provides extractables and leachables testing for consumer healthcare packaging, including plastic and glass bottles, laminated tubes, and closures.
Our studies support the safety and quality of creams, ointments, oral care, and personal care products throughout development and shelf life.
Electronic Nicotine Delivery Systems (ENDS)
Specialized E&L testing for ENDS device components and e-liquid container closure systems.
Identification and quantitation
of components with the potential to migrate into e-liquids or vapors under ISO- 10993. Comprehensive analysis ensures compliance with FDA, TPD,
and other regulatory standards.
Our Analytical Capabilities
Resolian’s E&L assessments combine comprehensive organic and inorganic screening with diverse, fit for purpose sample preparation techniques.
This integrated, multi technique approach enables confident identification and quantification of extractables and leachables across a wide range of materials, matrices, and product types.
Sample Preparation Techniques
- Solvent extraction
- Ultrasonication
- Microwave assisted extraction
- Bespoke, product specific approaches
Analytical Platforms
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Headspace GC-MS (Volatile Organic Compounds)
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GC-MS and GC-FID (Semi-Volatile Organic Compounds)
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UPLC-UV and high resolution LC MS (Non-Volatile Organic Compounds)
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ICP-MS and ICP-OES (Inorganic and Elemental Species)
Our Comprehensive Extractables and Leachables Testing Services
Regulatory-Aligned E&L Study Design: FDA, EMA, ISO 10993, and ICH Guidelines
Risk based, product specific study designs aligned with intended use, materials, and lifecycle stage. Data generated support regulatory submissions, manufacturing changes, device modifications, and supplier qualification.
Characterization of Unknowns
Resolian specialises in the characterisation of unknown compounds, applying advanced analytical expertise to support structural elucidation and informed safety assessment.
Accelerated Leachable Studies
Accelerated studies provide early insight into potential leachables over the intended shelf life, supporting stability planning and timely development decisions.
Toxicological risk assessment
The data generated by Resolian’s E&L studies can be used to support human health risk assessments, delivered in collaboration with leading toxicology consultants.
E&L Screening Studies
Comprehensive organic and inorganic screening strategies enable identification and quantification of compounds of interest across a wide range of materials and formulations.
Validation of Leachable Assay Methods
Targeted analytical methods are developed and validated to monitor leachables during stability studies and across the product’s shelf life, supporting ongoing product safety and control.
Our Analytical Sciences Resources
Frequently Asked Questions: Extractables and Leachables Testing.
Find answers to commonly asked questions about extractables and leachables testing at Resolian.
What is extractables and leachables testing?
Extractables and leachables (E&L) testing provides vital information concerning the potential for impurities deriving from container closure systems, drug delivery devices and manufacturing processes.
This contamination can present a risk in terms of both patient safety and product efficacy.
Where are Resolian's E&L testing laboratory locations?
Resolian operates dedicated extractables and leachables testing facilities in the UK, providing pharmaceutical, medical device, and biopharma clients with accessible, locally managed E&L services backed by globally harmonized quality systems.
Our analytical sciences laboratories in Fordham, serve as a specialist hub for E&L testing in Europe, operating under GMP/GLP conditions and MHRA oversight. For US-based programs, our Malvern, Pennsylvania facility provides equivalent capability with FDA inspection-ready status. Assay methods and data formats are fully harmonized across sites, meaning your study can be managed locally with global regulatory reach – whether you are submitting to the FDA, EMA, or MHRA.
For clients seeking an E&L testing laboratory in the UK or a contract research organization for extractables and leachables in Europe, Resolian’s Fordham site offers rapid project initiation, direct access to senior scientists, and a single point of contact for the full study lifecycle.
