Characterization of Impurities

The High Throughput Experimentation department of InKemia IUCT group has vast experience working in the pharmaceutical sector solving regulatory requirements related to impurities, all this thanks to a multidisciplinary team of organic chemists and analysts highly qualified.

The activities that InKemia IUCT group can perform in this field are:

  • Development and validation of analytical methods for determination of related substances
  • Determination of impurities’ profile
  • Obtention of impurities by forced degradation
  • Isolation and purification of impurities from pharmaceutical products
  • Structural elucidation of isolated related substances (Synthesis of related substances to use as analytical standards or to confirm the structure of a previously isolated impurity)

Analytical Techniques

  • Preparative HPLC
  • Analytical HPLC
  • MS, MS-MS and MS Exact
  • 1H and  13C NMR
  • FTIR