Development of an Efficient Process for a Diagnostic Test Agent (Bentiromide) and Identification, Synthesis, Characterization, and Control Strategy for Potential Impurities

Abstract

Abstract: The latest development studies provide a more effective and suitable process for Bentiromide (1), a diagnostic test substance. The enhanced procedure includes process modifications to get a better yield (76%) and high purity (above 99.8%) of Bentiromide (1). The current studies also outline a commercially viable method for removing important process-related impurities (A, B, C, D, E, F & G) in Bentiromide (1). During the impurity profile research, seven critical process-related impurities were found. These impurities were identified using high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) techniques. The synthesis schemes and spectral analysis data (MS, IR, 1H NMR, and 13C NMR) were used to characterize and confirm these impurities' structures. All of these impurities sources were investigated, identified, and strict control measures were taken to reduce them to an acceptable level.