Pharmaceutical Packaging

Extractables Components

Extractables are organic and inorganic chemicals that can be released from a packaging or drug release system, packaging component, or packaging material under specific conditions during laboratory testing.

Leachables Components

Leachables are organic and inorganic chemicals that can be released from a drug packaging or release system, from a packaging component or packaging material under normal storage and use conditions, or during accelerated pharmaceutical product stability studies.

“Leachable” components are typically a subset of extractables, or derived from extractable substances. Note that chemicals can also migrate from packaging or release systems to patients via direct contact.

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Pharmaceutical Packaging

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Pharmaceutical Packaging