Extractables and Leachables Testing

"Extractus delivers gold-standard Extractables and Leachables testing, combining cutting-edge technology, world-class expertise and an unwavering commitment to quality."

Rick Reiley, Chief Scientific Officer, Extractus

Extractables and Leachables testing shouldn’t be confusing slow inaccurate guesswork expensive generic unsupported

Samantha Gan ExtractusMany companies overpay for Extractables and Leachables testing. You shouldn’t have to face hidden costs, slow turnaround times, underqualified analysts, poor quality data, and generic testing that fails to meet your specific needs. Regulatory standards are complex, and choosing the right provider is difficult when so many labs appear the same. Worse, many suppliers offer little support or guidance, leaving you to interpret critical results alone. Extractus solves these problems with expert-led testing, transparent pricing, industry-leading technology, and a tailored approach that ensures accurate, compliant, and timely results. Our team of specialists not only delivers high-quality data but also provides clear interpretation and ongoing support, helping you avoid costly mistakes.” Samantha Gan, CEO – Extractus

Risk Assessments

We help you to document your E&L risks based on probability and severity, and provide solution focused recommendations to meet regulatory standards.

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Extractables

We perform high quality simulated and traditional  extraction studies to assess the risk of harmful compounds migrating into your products.

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Leachables

We conduct ICH compliant leachable studies on your behalf, providing expert advice and method development / validation to support you through the regulatory process.

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Accuracy & Compliance

Extractus delivers precise, fully compliant results, helping you avoid regulatory setbacks, reduce risk, and gain confidence in the safety of your products

Transparent Pricing

With Extractus, you get transparent E&L testing pricing – a core commitment that ensures clarity, puts you in control, and eliminates hidden fees

Fast & Reliable

Extractus delivers fast and reliable E&L testing, providing timely results to keep your product development on schedule and mitigate delays

Extractables and Leachables Lab Testing Equipment

About Us

Operating from a state-of-the-art laboratory in Oxfordshire, we are dedicated to delivering high quality, comprehensive extractables and leachables risk assessments, testing and recommendations.

As seasoned experts in the pharmaceutical, consumer health, and medical device industries, we specialise in handling a diverse range of products including OINDP (orally inhaled and nasal drug products), parenterals, ophthalmic drug products, and medical devices. We also have a wealth of experience in consumer health products such as topical and oral liquid formulations.

We operate under the ISO 17025 standard, developing and validating methods according to ICH Q2(R2) to ensure that any data generated can be used for regulatory submissions.

The US Food and Drug Administration (FDA) discusses common review issues encountered in ANDA applications on extractables/leachables studies, the kind of information FDA is looking for and how the FDA evaluates extractables/leachables data in ANDA applications.

You can rely on us to maintain the highest standards because we follow the guidance laid out by ICH. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards. 

Extractables are compounds that can be extracted from packaging or device components under controlled, often exaggerated, conditions, while leachables are compounds that migrate into the drug product from the packaging under normal storage or use conditions.

GET IN TOUCH NOW

Contact us today to discuss your needs.

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Led by industry veterans, Extractus delivers gold-standard Extractables and Leachables testing, combining cutting-edge technology, world-class expertise, and an unwavering commitment to quality. More than just data, we provide clear interpretation and strategic regulatory support, empowering you to make confident decisions. Unlike competitors that rely on hidden fees, outdated lab equipment, or underqualified staff, Extractus ensures you get accurate, reliable, and regulatory ready results that are right the first time, every time.

© Extractus 2025