Definitions of Extractable and Leachables
| Characteristic of the Interaction | Value for an Extractable | Value for a Leachable |
|---|---|---|
| Donor phase | Material, component or system that may be used to manufacture, store or deliver a finished drug product | System that is used to manufacture, store or deliver a finished drug product |
| Receiving phase | Extracting solvent1 | Finished drug product |
| Conditions of contact | Laboratory conditons2 | Conditions of actual use |
↵Notes: 1The extracting solvent may or may not be chemically similar to the finished drug product, depending on the purpose of the chemical assessment.
↵2The laboratory conditions may or may not be similar to the conditions of actual use, depending on the purpose of the chemical assessment. Nevertheless, the laboratory conditions typically are designed to accelerate, or even exaggerate, to some extent, the conditions of actual use.