| CAS No. | CATO-C4X-301131 |
| Molecular Formula | C29H31ClO7 |
| Molecular Weight | 527.01 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Ertugliflozin impurity 31 (CAS CATO-C4X-301131) is a certified pharmaceutical impurity reference standard with the molecular formula C29H31ClO7 and a molecular weight of 527.01 g/mol.
Based on its molecular formula C29H31ClO7, Ertugliflozin impurity 31 contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 527.01 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
As a certified reference material (CRM), Ertugliflozin impurity 31 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
| Molecular Formula | C29H31ClO7 |
| Molecular Weight | 527.01 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |