Download | March 6, 2013
Development Services: South San Francisco Development Center
Source: Patheon Inc.Drug substance analysis
- FTIR and appearance
- Polarized and hot stage microscopy
- TGA/DSC, pXRD and DMS
Preformulation assessment
- Aqueous and solvent solubility
- KF, pKa and log P
- Solution and solid state stability
Analytical method development
- Non-GMP
- Stability indicating
- Assay and degradants
- Related substances
Salt selection and polymorph screening
- New forms
- Relative thermodynamic stability
In vivo dosing and safety study formulation
- Vehicle selection
- Non-GLP manufacture
- Stability
Phase I formulation development (non-GMP)
- Excipient compatibility
- Stability and dissolution