| CAS No. | 2169998-23-4 |
| Molecular Formula | C21H23ClO7 |
| Molecular Weight | 422.86 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Dapagliflozin Impurity 20 is closely related to a flavonoid core, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Dapagliflozin Impurity 20 (CAS 2169998-23-4) is a certified pharmaceutical impurity reference standard with the molecular formula C21H23ClO7 and a molecular weight of 422.86 g/mol.
Structurally, Dapagliflozin Impurity 20 (C21H23ClO7) contains a flavonoid core, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 422.86 g/mol, it falls into the moderately-high-molecular-weight range. 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 | C21H23ClO7 |
| Molecular Weight | 422.86 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >90% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1998 |
| Halogen Content | Cl-containing |