Extractables and leachables in pharmaceutical packaging systems according to USP 1663 and USP 1664

We offer extractables and leachables testing 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 conditions used (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 to profile 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).

The tests are always customized for the product's specific needs.

Our experts are happy to help with any questions related to the tests and prepare a quote for you. Contact us with your testing needs through the form below, and we will get back to you.