Process Research & Development

Accelerating, transforming challenge into success

Impurity Synthesis & Study

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