| CAS No. | CATO-C4X-113856 |
| Molecular Formula | C15H34O6Si3 |
| Molecular Weight | 394.68 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a process- or degradation-related impurity, Dapagliflozin Impurity 56 (CAS CATO-C4X-113856, C15H34O6Si3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Dapagliflozin Impurity 56 (C15H34O6Si3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage. 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.
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 | C15H34O6Si3 |
| Molecular Weight | 394.68 g/mol |
| Purity | >95% |
| Storage | Store at room temperature, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Stable under recommended storage conditions |
| Degree of Unsaturation (DBE) | -1.0 |