Extractables and leachables in pharmaceutical packaging (USP 1663 & USP 1664)
We offer extractables and leachables (E&L) testing according to USP <1663> and USP <1664> to identify and quantify potential contaminants that could migrate from pharmaceutical packaging systems into the drug product.
Extractables are organic and inorganic chemicals released from pharmaceutical packaging into an extraction solvent under laboratory conditions. The specific testing conditions (e.g., solvents, temperature) are chosen to simulate potential stresses on the packaging and differ depending on the extraction study's purpose.
Leachables are organic and inorganic chemical compounds that migrate from pharmaceutical packaging materials, components, or systems into the drug product under simulated use conditions. These conditions are tailored to represent the drug product's shelf life, storage, and administration, enabling a realistic assessment of potential patient exposure.
Examples of analytical techniques used to characterize potential contaminants include:
HS-GC for volatile organic compounds.
GC-MS for semi-volatile organic compounds.
LC-MS for non-volatile organic compounds.
ICP-MS for inorganic elements (metals).
E&L tests are always customized to the specific product that is studied. Contact our experts using the form below to get a quote for your material.
- Suitable sample matrices
- Pharmaceutical packaging
- Available quality systems
- Measurlabs validated method
- Standard
- Method expert
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Questions? We're happy to help.
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