Itraconazole Impurity 64 CAS 2570971-58-1
| CAS No. | 2570971-58-1 |
| Molecular Formula | C12H16N4O |
| Molecular Weight | N/A |
| 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.
Itraconazole Impurity 64 (CAS 2570971-58-1) is a certified pharmaceutical impurity reference standard with the molecular formula C12H16N4OHCl and a molecular weight of 268.75 g/mol.
The molecular framework of Itraconazole Impurity 64 (C12H16N4OHCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C12H16N4O HCl |
| Molecular Weight | 268.75 g/mol |
| Purity | >85% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2001 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 4 |
Related Itraconazole Standards
- Itraconazole Impurity 44 (CAS 103661-14-9)
- Itraconazole Impurity 41 (CAS 106461-41-0)
- Itraconazole Impurity 93 (CAS 110762-98-6)
- Itraconazole 2-Oxo Metabolite (CAS 112560-33-5)
- Itraconazole Impurity 38 (CAS 115897-54-6)
- Itraconazole N-Formyl-Ethlene Impurity (CAS 1199350-00-9)
- Itraconazole Impurity 73 (CAS 1199350-02-1)
- Itraconazole-d5(major) (CAS 1217510-38-7)
Recommended Standards
- Elagolix Impurity 10 (CAS CATO-C4X-206810)
- Picosulfate impurity 19 (CAS CATO-C4X-123719)
- Orforglipron impurity 25 (CAS 443-86-7)
- 2-Azabicyclo[4.2.0]octa-4,6(1)-dien-3-one (CAS 85728-10-5)
- 2-Amino-5-[(4-methylphenyl)methyl]-5-phenyl-4,5-dihydro-1H-imidazol-4-one (CAS 1354923-36-6)
- Talazoparib Impurity 4 (CAS 1322879-81-1)
- 1-[2-(dimethylamino)phenyl]ethan-1-ol (CAS 104524-50-7)
- 5-(tert-Butyl)-3-(methylthio)-1,2,4-triazine (CAS 69249-25-8)
- 5-(3-Methoxy-4-((4-methylbenzyl)oxy)phenyl)-1,3,4-oxadiazol-2-amine (CAS 1706439-76-0)
- Biotinyl-S6 Phosphate Acceptor Peptide trifluoroacetate salt (CAS 1815618-12-2)
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