Synthesis and Characterization of Process Related New Impurity in Ufiprazole

Author(s): Dr. Sandip Sadaphal,* Huang Xiangliang, Rajesh Ambre, Sonal Chothe, Wei xiong and Xu cong

Impurities identification, synthesis and its control are the key factor for drug quality and specification. Impurity study enhances scope towards better production of drug molecules.New impurities 5-methoxy-1-((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)-2-((4-methoxy-3,5-dimethylpyridin-2-yl)methylthio)-1H---benzo[d]imidazole and 6-methoxy-1-((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)-2-((4-methoxy-3,5-dimethylpyri-din-2-yl)methylthio)-1H-benzo[d]imidazole have been identified, synthesized and analyzed in ufiprazole (5-methoxy-2-((4-methoxy-3,5-dimethylpyridin-2-yl)methylthio)-1H-benzo[d]imidazole). Both dimer impurities were isolated with HPLC purity more than 98% and characterizedby IR, 1H-NMR, 13C-NMR and LCMS.


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