Extractables are compounds that CAN be forced to migrate from the contact material into a solvent under fairly aggressive extraction conditions such as extended time, elevated temperature or different solvents. The point of extractables screening is to assess what MIGHT migrate.
Leachables are compounds that DO migrate from the contact material into the drug product or medical device under normal conditions of storage. The substances of concern typically come from plastic components, elastomers, coatings, accelerants, antioxidant, inks and adhesives.
Design and conduct appropriate extractables studies to identify potential leachables from the materials used in the manufacture, storage or delivery of your product
GC/MS for volatile and semi-volatile organics
HPLC-diode array (DAD)-TOFMS for semi and nonvolatile organics
ICP/MS or ICP/OES for trace metals
QTOFMS or MS/MS also available to aid in unknown identification
Other techniques when appropriate
At Aspen Research, our scientists and technical experts have a long history of working with medical device, pharma, biotech and their suppliers as well as suppliers to food companies. Our ability to give you expert advice and analytical solutions makes us the perfect partner to support your Extractables & Leachables project.
We have extensive experience in polymer analysis and are experienced at designing and conducting appropriate studies to assist with both regulatory and process concerns. Aspen is an ISO accredited laboratory and utilizes ISO 17025 validated test methods when appropriate for extractables testing.