Ketoconazole Impurity 18 CAS 13256-06-9
| CAS No. | 13256-06-9 |
| Molecular Formula | C10H22N2O |
| Molecular Weight | 186.29 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Ketoconazole Impurity 18 is closely related to an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Ketoconazole Impurity 18 (CAS 13256-06-9, C10H22N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Ketoconazole Impurity 18 (C10H22N2O) contains an amide group, a hydroxyl group, an ether linkage. 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), Ketoconazole Impurity 18 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.
Physical & Chemical Properties
| Molecular Formula | C10H22N2O |
| Molecular Weight | 186.29 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 1.0 |
| CAS Registry Year (est.) | 1960 |
| Nitrogen Atoms | 2 |
Related Ketoconazole Standards
- Ketoconazole Impurity 16 (CAS 2234-16-4)
- Ketoconazole Impurity 15 (CAS 581806-59-9)
- Ketoconazole Impurity 17 (CAS 67914-60-7)
- Ketoconazole Impurity 7 (CAS 172032-21-2)
- Ketoconazole Impurity 21 (CAS 129643-72-7)
- Ketoconazole Impurity 23 (CAS 29098-85-9)
- Ketoconazole Impurity 24 (CAS CATO-C4X-147224)
- Ketoconazole Impurity 22 (CAS CATO-C4X-147222)
Recommended Standards
- Sodium Valproate EP Impurity D (CAS 52061-75-3)
- Lidocaine Impurity 50 (CAS 27794-54-3)
- octyl propionate (CAS 142-60-9)
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- Verapamil EP Impurity I (CAS 2893-91-6)
- Sermorelin Impurity 2 (CAS CATO-C4X-23422)
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