Extractables and leachables questions

What is extractables and leachables testing?

It is obviously undesirable for a medication or a medical device to introduce unwanted substances to the human body. E&L testing investigates substances (organic and inorganic) that probably will be and possibly could be released to a patient form medical devices, pharmaceutical production and pharmaceutical packaging. The aim is to identify and quantify chemical species to allow an informed toxicological risk assessment.

Extractables and leachables definition

Leachables are materials which are likely to migrate into drug products during storage or production. They can subsequently be identified in laboratory investigations.

Extractables could similarly find their way into medications but with a lower probability. They are identified in the laboratory using ‘forced’ extraction.

In the case of medical devices leachables are substances that are likely to be released to a patient during use. Extractables are materials that could be released in long term use or if the device is damaged.