| CAS No. | 3373-10-2 |
| Molecular Formula | C16H26 |
| Molecular Weight | 218.38 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a process- or degradation-related impurity, Amorolfine Impurity 57 (CAS 3373-10-2, C16H26) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Amorolfine Impurity 57 (C16H26) contains 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 high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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), Amorolfine Impurity 57 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 | C16H26 |
| Molecular Weight | 218.38 g/mol |
| Purity | 97%+ |
| Storage | Store at room temperature |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate |
| Stability | Stable under recommended storage conditions |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |