Leachables and Extractables in Pharmaceuticals
Extractables are organic and inorganic chemical entities that can be released from a test article and into an extraction solvent under laboratory conditions.
Test articles include packaging systems, delivery systems, manufacturing suites and/or their associated materials or components of construction.
Extractables themselves, or substances derived from extractables, have the potential to leach into a drug product under normal conditions of storage and use and become leachables. Thus, extractables are potential leachables.
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