Extractables & Leachables
At Genuine Testing, we provide comprehensive Extractables and Leachables analysis to ensure the safety, quality, and compliance of materials that come into contact with drug products, food, or medical devices. Our Extractables and Leachables testing identifies and quantifies potentially harmful chemicals that may migrate from packaging, containers, or components into your product.
Why Choose Genuine Testing for E&L Testing?
Regulatory Expertise
We design and execute testing strategies that align with current regulatory guidelines and industry standards.Advanced Analytical Tools
Our laboratory is equipped with sensitive, state-of-the-art instrumentation for detecting even trace-level contaminants.Cross-Industry Experience
We work with pharmaceutical, medical device, food contact, and consumer product manufacturers.End-to-End Support
From method development and validation to data interpretation and reporting, we guide you through the entire process.
What Are Extractables & Leachables?
Extractables are compounds that can be extracted from materials under exaggerated conditions (e.g., high heat, solvents).
Leachables are compounds that actually migrate into the product under normal storage or use conditions.
Both can pose safety risks and impact product performance, making their identification and quantification critical for regulatory approval and product integrity.
Our Extractables & Leachables Testing Capabilities
We offer customized E&L testing programs, including:
Controlled extraction studies (extractables)
Simulation and real-time storage studies (leachables)
Identification and quantification of organic and inorganic compounds
Risk assessment and toxicological evaluation
Method development and validation
Techniques we employ:
Gas Chromatography-Mass Spectrometry (GC-MS)
Liquid Chromatography-Mass Spectrometry (LC-MS/MS)
Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Fourier Transform Infrared Spectroscopy (FTIR)
Headspace GC and Thermal Desorption
Applications & Industries
Our Extractables and Leachables analysis serves:
Pharmaceuticals & Biologics — primary and secondary packaging, container-closure systems
Medical Devices — catheters, tubing, syringes, implantable devices
Food Contact Materials — packaging films, containers, coatings
Cosmetics & Personal Care — packaging and applicators