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Synthesis and Characterization of Potential Impurities of Canagliflozin
Author(s) -
Pachore Sharad S.,
Akula Swapna,
Aaseef Mohammad,
Usha Jyothi Mudumbai,
Vemuri Sasikala,
Prakash Lakki Reddy,
Vidavulur Siddaiah,
Sonawane Swapnil P.,
Syam Kumar Unniar K.,
Dahanukar Vilas H.
Publication year - 2017
Publication title -
chemistryselect
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.437
H-Index - 34
ISSN - 2365-6549
DOI - 10.1002/slct.201701973
Subject(s) - impurity , characterization (materials science) , materials science , chemistry , canagliflozin , organic chemistry , nanotechnology , medicine , endocrinology , type 2 diabetes , diabetes mellitus
Multiple sources of anticipated process and degradation impurities of canagliflozin drug has been identified during its laboratory optimization and later in commercial scale manufacturing process. The structure of these impurities were confirmed by their independent synthesis as well as by their complete spectral characterization including 2D NMR, 19 F NMR, and their chromatographic retention time profile. As a part of these investigations, three new impurities such as Hydroperoxide (Impurity‐D), Sulfone (impurity‐F) and Dimer (impurity‐C) were characterized. The present work describe our detailed investigations on the structural characterization of canagliflozin impurities, and further their independent synthesis.