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

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.