Acceledev is well equipped to perform the following activities as part of any API process development program.
- Impurity isolation and identification using prep-HPLC, LC-MS, GC-MS, FT-IR and NMR spectroscopy
- Synthesis & isolation of key impurities to support internal needs or those of our customers
- Forced degradation study for the detection of impurities or degradation products
- Stability studies under varied temperatures and humilities per ICH guidelines
- Genotoxic and elemental impurity method development and validation
- Reference standards characterization and qualification