Identification, synthesis and structure assignment of two impurities of Erlotinib, a drug used for the treatment of some types of cancer.

In the synthesis and industrial production of Erlotinib, the formation of organic impurities has been detected, so the identification and control of these is a critical point within the process. Standards for the consumption of pharmaceutical products are well established for active substances. In this sense, the synthesis and unequivocal identification of two impurities of Erlotinib as structural isomers was developed in the present study. The structural characterization of both isomers was confirmed by 1H and 13C-NMR as well as by their X-ray diffraction study.