"NCE Characterization",
please contact our team.
In the pre-clinical stage, via systematic salt and solid-state form screening, we provide services to our partners to identify the ideal salt and most stable solid form to mitigate the form conversion risk down the road. Our services also cover the characterization of other essential properties of NCEs to support the pre-clinical, clinical dosage form and manufacturing process development.
Salt form and polymorph screening, characterization, stability study, and in vivo PK evaluation when needed
Solubility: pH solubility, Solubility in FaSSIF, Solubility in FeSSIF, Solubility SGF, Solubility in suspension vehicles, co-solvent, surfactants, lipids, and others
Stability: pH stability, stability in biorelevant medium, forced degradation in solution and solid state, and photostability study
Log P, pKa
Permeability
Thermal characterization via DSC/TGA
Intrinsic dissolution
Moisture sorption
Power characterization: particle size and size distribution, particle morphology, repose angle, bulk density, Tap density, Surface area, Flow ability, Compressibility, Wettability, mechanical stability
Excipient compatibility