| CAS No. | 21739-92-4 |
| Molecular Formula | C7H4BrClO2 |
| Molecular Weight | 235.46 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
| Molecular Formula | C7H4BrClO2 |
| Molecular Weight | 235.46 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at room temperature, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1963 |
| Halogen Content | Cl/Br-containing |