Frequently Asked Questions
11. What is an extractable?
An extractable is a compound that can be extracted from
a) the device components or surfaces of a drug/ENDS/e-liquid product container
b) the single use disposable components or surfaces of an API/BDS or drug product manufacturing process
They are individual chemical entities that can be extracted from components (e.g. plastic and/or elastomeric stoppers, tubing, gaskets, bottles, bags, connectors, vials, etc) in the presence of an appropriate solvent under relatively vigorous laboratory conditions. As such, extractables can be considered as potential leachables in the final drug product
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