In the synthesis of Esmolol hydrochloride four prominent process impurities were formed during synthesis. These impurities were detected in gradient HPLC method. These impurities are synthesized in different synthesis methods and characterized as 3-(4-(2-hydroxy-3-(isopropyl amino) propoxy) phenyl)propanoic acid (Esmolol free acid), Methyl 3-{4- [3-(ethyl amino)-2-hydroxy propoxy]phenyl} propionate (Esmolol isopropyl amide analog), 3-(4-(2-hydroxy- 3(isopropylamino)propoxy)phenyl)-N-isopropylpropanamide (N-Ethyl Esmolol), Methyl 3-(4-(2-hydroxy-3-(3-(4-(2- hydroxy-3-(isopropylamino) propoxy) phenyl)-N-isopropyl propanamido) propoxy)phenyl)propanoate (Esmolol dimer) by 1H NMR, IR and Mass spectral data. Synthesis and Structural elucidation by spectral data is discussed.
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