Research Paper Identification, Synthesis and Characterization of P otential Impurities of Dexlansoprazole
Abstract
Research work featured in this article describes th e synthesis and characterization of related substance of Dexlansoprazole (( R)-(+)-1); the successor and ( R)-enantiomer of Lansoprazole with an enantiomeric excess of >99.8% and ICH grade quality of final API. During the laboratory development and scale up, we have observed six possible potenti al impurities in the selected synthetic sequence Vi z., Nitro sulfone, Levo Nitro sulfoxide, lansoprazole s ulfide, Lansoprazole sulfone, Spiro compound and Levo Dexlansoprazole.
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