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
“Many 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.
Extractables
We perform high quality simulated and traditional extraction studies to assess the risk of harmful compounds migrating into your products.
Leachables
We conduct ICH compliant leachable studies on your behalf, providing expert advice and method development / validation to support you through the regulatory process.
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
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.
Extractables and Leachables FDA Guidance
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.
How do Extractus maintain quality testing?
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.
What is the difference between Extractables and Leachables?
Extractables are chemical compounds that can be forcibly removed from a material, such as plastic, rubber, or glass, under aggressive conditions like high heat or strong solvents. Leachables, on the other hand, are substances that migrate naturally into a drug product or biological system over time under normal use conditions.
The study of Extractables and Leachables (E&L) originates from pharmaceutical, medical device, and food packaging industries, where contamination control is critical. Extractables testing helps predict potential leachables, ensuring regulatory compliance and patient safety.
Extractables analysis identifies potential risks by simulating extreme conditions, while leachables testing confirms real-world exposure risks in actual storage and use scenarios. Both are essential for ensuring product safety and regulatory approval.
As regulators like the FDA and EMA tighten guidelines, manufacturers must rigorously assess materials for extractables and leachables to maintain product integrity.
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.
Quick Links
Get In Touch
© Extractus 2025