ENG
Solution & Service
NCE Characterization

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.

NCE Characterization includes but not limited to

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