IMPURITY CHARACTERIZATION

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