Paragraph 17 Characterisation

Each test and reference substance should be appropriately identified (e.g. code, chemical abstract number (CAS), name).

For each safety study, the identity, including batch number, purity, composition, concentrations, or other characterisations to appropriately define each batch of the test or reference substances should be known.

The stability of test and reference substances under conditions of storage should be known for all studies.

The stability of test and reference substances under the test conditions should be known for all studies.

If the test substance is administered in a vehicle, standard operating procedures should be established for testing the homogeneity and stability of the test substance in that vehicle.

A sample for analytical purposes from each batch of test substance should be retained for studies in which the test substance is tested for longer than four weeks.