The measurement of the stability of a drug in conditions that mimic the gastrointestinal tract, physiological conditions and/or in vitro biological conditions helps in identifying and understanding the lability of molecules due to non-enzymatic processes.
High chemical instability could result in aberrant in vitro biological data or issues with pharmacokinetics profiles following oral dosing.
Sygnature’s chemical stability assay measures the stability of a test compound in a desired matrix (e.g. buffer at different pH’s or in a simulated gastric fluid environment (FaSSIF, FeSSIF, FaSSGF)). The molecule to be tested and controls (positive) are incubated in the matrix for a defined period and the percent remaining and half-life determined.
Diclofenac or omeprazole are included as positive control compounds.