Dapagliflozin Impurity 58

Stability indicating rp-​hplc method for simultaneous estimation of dapagliflozin and saxagliptin in pharmaceutical dosage forms
By Thota, Hanisha; Soundarya, G.
From Journal of Global Trends in Pharmaceutical Sciences (2021), 12(1), 9131-9137
 
Method development and validation of a stability-​indicating reversed-​phase liquid chromatographic method for the simultaneous estimation of metformin and dapagliflozin in presence of their degradation products
By Kotecha, Nidhi; Patel, Jayvadan
From International Journal of Pharmaceutical Sciences Review and Research (2019), 56(2), 1-6.
 
Validation of a newly developed stability indicating RP-​liquid chromatographic method for the quantitative determination of dapagliflozin
By Sura, Sreenivasulu; Modalavalasa, Rameswara Rao; Kothapalli, ChandraSekhar B.
From Pharma Chemica (2018), 10(1), 93-102
 

Dapagliflozin Impurity 58 is chemically (2S,3R,4S,5R,6R)-6-(Acetoxymethyl)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-2-(((2R,3R,4S,5R)-3,4,5-triacetoxy-6-oxotetrahydro-2H-pyran-2-yl)methoxy)tetrahydro-2H-pyran-3,4,5-triyl triacetate. Dapagliflozin Impurity 58 is supplied with detailed characterization data compliant with regulatory guideline. Dapagliflozin Impurity 58 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Dapagliflozin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.