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Extractables
and Leachables
(E&L)

Comprehensive extractables and leachables testing to ensure product safety, regulatory compliance, and patient well-being.

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hex-icon A Trusted Partner in Extractables and Leachables Testing

Extractables and leachables (E & L)  testing identifies chemical compounds that may migrate from medical devices or packaging into patients or drug products.

Broughton's extractables and leachables testing services provide clients with comprehensive analysis to identify potential contaminants that may migrate from packaging, container closure systems, or manufacturing processes into the final product. 

Our experienced team conducts E&L studies under international regulatory guidelines, ensuring products are safe for their intended use.

hex-icon Our Capabilities

Extractables Studies


Conducting controlled extraction studies to identify potential extractable compounds under exaggerated conditions.

Leachables Studies

Conducting simulated-use studies to detect compounds that may migrate into the product under normal storage and usage conditions.

Analytical Method Development and Validation

Developing and validating sensitive analytical methods to accurately detect and quantify extractables and leachables.

Toxicological Risk Assessment

Evaluating the safety of identified compounds through toxicological assessment to determine potential risks to patients.

Material Characterisation

Analysing materials used in packaging and manufacturing to understand their composition and potential to release harmful substances.

Regulatory Support

Providing comprehensive documentation and expert guidance to support regulatory submissions and compliance.

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hex-icon Who We Support

Our E & L testing services are designed to meet the needs of a wide range of clients, ensuring that products are safe for their intended use and compliant with relevant regulations. 

Industries we support include:

hex-icon Why Broughton

Broughton provides E & L  testing with scientific precision and regulatory confidence. Our team understands the critical role E&L studies play in ensuring product safety, supporting approvals, and protecting patients. Whether you require standalone testing or a fully integrated service, we deliver clear, actionable results aligned with your development goals.

Specialist Knowledge: Deep expertise in material science, analytical chemistry, and toxicology

Regulatory Alignment
: Studies designed to meet the expectations of global health authorities

Flexible Study Design
: Programmes tailored to product format, material type, and risk profile

Seamless Integration
: Option to combine with toxicology consultancy, stability testing, or batch release for end-to-end support
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Knowledge Centre

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