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Extractables and Leachables

Extractables are compounds that can migrate from a container/delivery system under stressed laboratory conditions.  Leachables are compounds that can migrate from a container/delivery system into a drug product under ordinary use conditions. Understanding the potential of both is essential to judge whether materials of construction of a system are compatible with a drug product. This section presents papers on experimental methods for identifying compounds, strategies for evaluating risks, and similar important topics.

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