Frequently Asked Questions
12. What is a leachable?
A leachable is a compound which is present in the final drug/ENDS/e-liquid product due to leaching from
a) the device components or surfaces of a drug/ENDS/e-liquid product
b) the disposable single use components or surfaces of an API/BDS or drug product manufacturing process
Leaching can be promoted by the formulation, or components of the formulation, for example the organic propellants used in metered dose inhalers. Leachables are often a subset of, or are derived directly or indirectly from extractables. However not all leachables will necessarily be found during the extractables study. For example, formulation components or buffers may interact with a polymer or its additives, to form a new 'leachable' contaminant, not present during the original extractables study.
As leaching is essentially a time dependent, diffusion driven process, leachables are generated over the shelf-life of a product. The extent to which this occurs is determined during appropriate leachable and/or accelerated leachable studies (see Q10).
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