Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry


Identification, Synthesis and Characterization of Process Related Impurity of Male Hormone Testosterone Undecanoate

Author(s): Kishor R More, Avinash M Nijasure

An unknown impurity observed in API testosterone undecanote was identified, synthesized and characterized using modern analytical techniques. Liquid chromatography–mass spectrometry (LC-MS) data revealed that the molecular weight of the impurity is two protons less than the API indicating presence of one additional double bond in the structure. Further the position of the double bond was confirmed by its synthesis. It is found to be the process related impurity.