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The journey of extractables and leachables


Aspen Research Laboratories is a CRO known for its superior understanding of materials science, engineering and analytical testing. Its scientists collaborate with pharma, medical device manufacturers, single-use suppliers, and many other industries to solve challenges and expedite product development.


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xtractables and leachables testing is done primarily to help ensure that a medical device or pharmaceutical packaging is safe


for its intended use. An extractable is defined as a substance – organic or inorganic chemical entity – that is released from a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles (solvents). A leachable is defined as a substance that is released from a medical device or material during its clinical use (ISO10993-18:2020) or as a foreign organic or inorganic chemical entity that is present in a packaged drug product, because it has leached into the packaged drug product from a packaging/delivery system, packaging component or packaging material of construction under normal conditions of storage and use, or during accelerated drug product stability studies (USP 1663 and 1664).


In the extractables testing field, there are no hard-and-fast rules as to which extracting solvents to use or what the times and temperatures of the extractions must be. There are, however, guidance documents and ISO standards that help direct appropriate testing. Given that the results of the testing are used in regulatory submissions for approval of medical devices and drug products, it is imperative that studies are designed to yield results that can be used to determine if the device or drug product is safe for the intended use.


Designing the extractables study As a contract analytical chemistry laboratory, Aspen Research Laboratories’ clients come to it to not only perform testing, but also to help advise on designing the study, along with performing the analyses involved in the study. This article analyses the journey of


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