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.
Download this free white paper to find out more.
Download to find out more.