Dapagliflozin Impurity 16 CAS 21739-92-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.21739-92-4
Molecular FormulaC7H4BrClO2
Molecular Weight235.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dapagliflozin Impurity 16 CAS 21739-92-4 chemical structure

Description

The occurrence of Dapagliflozin Impurity 16 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine/bromine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Dapagliflozin Impurity 16 (CAS 21739-92-4) is a certified pharmaceutical impurity reference standard with the molecular formula C7H4BrClO2 and a molecular weight of 235.46 g/mol.

The molecular framework of Dapagliflozin Impurity 16 (C7H4BrClO2) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine/bromine substitution, an aromatic ring 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).

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 FormulaC7H4BrClO2
Molecular Weight235.46 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1963
Halogen ContentCl/Br-containing

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