Efinaconazole Impurity 19 CAS 164650-45-7
| CAS No. | 164650-45-7 |
| Molecular Formula | C18H22F2N4O |
| Molecular Weight | 348.39 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Efinaconazole Impurity 19 (CAS 164650-45-7, C18H22F2N4O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Efinaconazole Impurity 19 (C18H22F2N4O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
Physical & Chemical Properties
| Molecular Formula | C18H22F2N4O |
| Molecular Weight | 348.39 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2004 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 4 |
Related Efinaconazole Standards
- Efinaconazole Impurity 18 (CAS 2055038-61-2)
- Efinaconazole Impurity 20 (CAS 2055038-60-1)
- Efinaconazole Impurity 23 (CAS CATO-C4X-124323)
- Efinaconazole Impurity 39 (CAS 2122222-10-8)
- Efinaconazole (CAS 164650-44-6)
- Efinaconazole Impurity 13 (CAS CATO-C4X-124313)
- Efinaconazole Impurity 40 (CAS 161287-08-7)
- Efinaconazole impurity 52 (CAS CATO-C4X-124352)
Recommended Standards
- Terbutaline impurity 101 (CAS 1226543-90-3)
- 2-[(3-{[(2-Methoxyethyl)amino]carbonyl}anilino)-carbonyl]cyclohexanecarboxylic acid 3809AF 940478-36-4 C18H24N2O5 (CAS 940478-36-4)
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