On Extractables and Leachables?

What is the difference between an extractable and a leachable? Extractables are compounds that can be extracted from a packaging component, delivery system, or manufacturing surfaces via laboratory manipulation, such as exposure to solvents or heat. Extractables can be potential leachables.

What is meant by extractables and leachables?

Extractables can be caused through gamma-irradiation (Shah et al, 2013). Leachables. Leachables are compounds that leach into the drug or biological product from the container-closure system such as the elastomeric or plastic components, or coatings of the container and closure system.

What is extractables testing?

Extractables and Leachables Testing is an analysis of potentially harmful materials that could be administered to a patient with a drug or device. ... Toxicological assessments may then be made, to quantify a patient's exposure to each chemical and gauge the level of risk posed by these materials.

Maya Lin-Takahashi

Maya Lin-Takahashi

Consumer Tech & Gadget Reviewer

Maya is a hardware enthusiast who tests and reviews smart home devices, smartphones, wearables, and audio gear. She focuses on practical consumer value and build quality.