Evaluation of the stability of novel chemical entities in various matrices including simple buffer solutions at different pH values, tissue culture media and simulated gastrointestinal fluids can facilitate in interpreting anomalous in vitro biological activity data, as well as in identifying compounds not be suitable as oral drug candidates.
The chemical stability assay examines the disappearance over time of a test compound in a selected matrix (e.g. a buffer with a specific pH, or a fasted or fed state simulated gastric or intestinal fluid). All tests have three replicates per compound, and are validated by inclusion of a positive control with known stability under the assay conditions.
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