Identification & Characterization of Impurities
Syngene develops either a suitable method or adapts an existing method for impurity isolation and characterization. Isolation of the impurities can be executed with preparatory HPLC using various detectors such as UV/ELSD/MS or supercritical fluid preparatory chromatography followed by detailed structure elucidation using MS and NMR techniques.
The results from impurity characterization studies can be presented as a formal report suitable for regulatory submissions. In addition, Syngene can characterize and potentially identify impurities and degradation products present in API. Impurities above 0.10% are also isolated or purified using prep HPLC/ prep SFC techniques.