| CAS No. | CATO-C4X-223631 |
| Molecular Formula | C11H12O |
| Molecular Weight | 160.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Epalrestat impurity 31 (CAS CATO-C4X-223631) is a certified pharmaceutical impurity reference standard with the molecular formula C11H12O and a molecular weight of 160.21 g/mol.
Epalrestat impurity 31 (C11H12O) contains a hydroxyl group, an ether linkage, an aromatic ring system. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Epalrestat 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 | C11H12O |
| Molecular Weight | 160.21 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |