Patheon offers the full breadth of advanced sciences to characterize the physicochemical properties of your drug substance to generate the data required to build a CMC package for your IND filing and lead the way to clinical trials. By maximizing the efficiency and flexibility of a non-GMP environment, and with all the equipment in close proximity, we are able to quickly analyze and explore even small amounts of material and keep your project moving forward.
Characterization includes solubility – as a function of pH, temperature, solvents, stability – at IHC conditions for API, solutions and formulations, and identification of formulation options for in-vitro and preclinical in-vivo studies.
By having physicochemical characterization seamlessly integrated into a complete early development program that is driven by an experienced dedicated team, Patheon is the most rapid and cost-effective way to go from molecule to market.
Drug Substance analysis
- FTIR and appearance
- Polarized and hot stage microscopy
- TGA/DSC, pXRD and DMS
- Aqueous and solvent solubility
- KF, pKa and logD
- Solution and solid state stability
Analytical method development
- Stability indicating
- Assay and degradants
- Related substances