Chemical Stability

Explore drug stability assessment under physiological conditions using Sygnature’s chemical stability assay. Learn about its significance in understanding molecule lability and potential impacts on biological data and pharmacokinetics.

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.