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Synthesis and Characterization of Metabolites and Potential Impurities of the Antiulcerative Drug Tenatoprazole
Authors:Ganta Madhusudhan Reddy  V. V. N. K. V. Prasada Raju  J. Moses Babu  Ch. Praveen  Mayur Khunt  K. Mukkanti
Affiliation:1. Research and Development API, Innovation Plaza, Dr. Reddy's Laboratories Ltd. , Hyderabad, Andhra Pradesh, India;2. Institute of Science and Technology, J. N. T. University , Hyderabad, India;3. Research and Development API, Innovation Plaza, Dr. Reddy's Laboratories Ltd. , Hyderabad, Andhra Pradesh, India;4. Institute of Science and Technology, J. N. T. University , Hyderabad, India
Abstract:Tenatoprazole (Ulsacare®) is a recently developed antiulcerative drug used for the treatment of both erosive and nonerosive gastroesophageal reflux disease. During the bulk synthesis of tenatoprazole, we have observed four impurities (tenatoprazole N‐oxide, tenatoprazole sulfone N‐oxide, N‐methyl tenatoprazole, and desmethoxy tenatoprazole) and two metabolites (tenatoprazole sulfide and tenatoprazole sulfone). The present work describes the synthesis and characterization of these impurities.
Keywords:Impurities  metabolites  sulfide and sulfone  synthesis  tenatoprazole
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