Dapagliflozin Impurity 3 CAS CATO-C4X-11383

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-11383
Molecular FormulaC42H48Cl2O12
Molecular Weight815.73 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dapagliflozin Impurity 3 CAS CATO-C4X-11383 chemical structure

Description

The molecular framework of Dapagliflozin Impurity 3 (C42H48Cl2O12) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a process- or degradation-related impurity, Dapagliflozin Impurity 3 (CAS CATO-C4X-11383, C42H48Cl2O12) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC42H48Cl2O12
Molecular Weight815.73 g/mol
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing

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