Pharmaceutical Packaging
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.