Characterization of Potential Eluxadoline Impurities: Identification and Synthetic Approach

Abstract

Eluxadoline is a novel active pharmaceutical ingredient (API) used in the treatment of diarrhea and abdominal pain associated with diarrhea-predominant irritable bowel syndrome (IBS-D). During its synthesis, five unknown impurities were identified, synthesized, and comprehensively characterized using various analytical techniques such as ¹H NMR, ¹³C NMR, mass spectrometry, and IR spectroscopy. These five process/degradation impurities are Eluxadoline diacid impurity (EDA impurity), Eluxadoline desmethyl impurity (EDM impurity), Eluxadoline desmethyldiacid impurity (EDMDA impurity), Eluxadoline amino methyl ester impurity (EAME impurity), and Eluxadoline Alcohol impurity (EA impurity). These impurities are crucial as reference standards for the development and quality control, regulatory compliance of the  active pharmaceutical ingredient manufacturers and research