d-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-,;
(2S,3R,4R,5S,6R)-2-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol [461432-26-8]
BRIEFING
Dapagliflozin. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure used in the Assay was validated using the Kromasil C18 brand of column with L1 packing. The typical retention time for dapagliflozin is about 4 min.
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The liquid chromatographic procedure used in the Organic Impurities test was validated using the Kinetex XB-C18 brand of column with L1 packing. The typical retention time for dapagliflozin is about 13 min.
Description and solubility information: White to off-white powder or solid. Freely soluble in dimethylsulfoxide; soluble in ethanol; slightly soluble in water.
(SM3: R. Fales)
Case ID—SUB-67, SUB-278