Extractables and leachables in pharmaceutical packaging systems by USP 1663 and USP 1664

We offer extractables and leachables (E&L) testing by 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: Detects volatile organic compounds.

• GC-MS: Identifies semi-volatile organic compounds.

• LC-MS: Characterizes non-volatile organic compounds.

• ICP-MS: Analyzes inorganic elements (metals).

E&L tests are always customized to the specific product that is studied. Contact our experts through the form below to get a quote for your material.