Extractables and leachables testing

Description

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. Price is dependent on the study design, including the required analytical test, number of time points and ambient versus accelerated conditions.

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.

To speak to our friendly expert team, please phone +44(0)1302 986 088 or email [email protected] today.

We look forward to speaking with you soon.

Our other product quality services include:

• E-liquid nicotine consistency & characterisation
• E-liquid stability shelf life testing
• Heavy metals testing
• Micro testing
• Nicotine potency testing
• Pesticides screening.