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Current Position: Home > Solution & Service

API & Intermediates
CDMO Service
Drug Product CDMO Service
Analytical Service
Support
Drug Product CDMO Service API & Intermediates CDMO Service Analytical Service Support
Drug Product CDMO Service

NCE Characterization

In 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:
(1)Solubility: pH solubility, Solubility in FaSSIF, Solubility in FeSSIF, Solubility SGF, Solubility in suspension vehicles, co-solvent, surfactants, lipids, and others;
(2)Stability: pH stability, stability in biorelevant medium, forced degradation in solution and solid state, and photo stability study;
(3) Permeability;
(4) Log P, pKa;
(5) Salt form and polymorph screening, characterization, stability study, and in vivo PK evaluation when needed;
(6) Thermal characterization via DSC/TGA;
(7) Intrinsic dissolution;
(8) Moisture sorption;
(9) Power characterization: particle size and size distribution, particle morphology, repose angle, bulk density, Tap density, Surface area, Flow ability, Compressibility, Wettability, mechanical stability;
(10)Excipient compatibility;