Extractables and leachables testing

Extractables and leachables testing

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.

America’s 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.