Extractables and leachables testing at two timepoints
Extractables and leachables testing is an analysis of harmful, or potentially harmful, components from the device or packaging of a product, following a specific period of controlled storage conditions. The length of time can be tailored to suit specific needs, usually one to three months.
The FDA defines the two terms as follows:
- Extractables are compounds that can be extracted from the container closure system when in the presence of a solvent
- Leachables are compounds that leach into the drug product formulation from the container closure system as a result of direct contact with the formulation.
Affordable, quality, accredited testing in our UK lab
Our team of scientists are passionate about delivering accurate, reliable scientific results that you can trust. They test in our ISO/IEC 17025:2017 accredited laboratory in Yorkshire, UK.
We look forward to speaking with you soon.
Our other product quality services include: