Itraconazole EP Impurity D CAS 89848-49-7
| CAS No. | 89848-49-7 |
| Molecular Formula | 2*C34H36Cl2N8O4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Itraconazole EP Impurity D (C34H36Cl2N8O4) 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).
Itraconazole EP Impurity D (CAS 89848-49-7) is a certified pharmaceutical impurity reference standard with the molecular formula C34H36Cl2N8O4 and a molecular weight of 691.61 g/mol.
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.
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 | 2*C34H36Cl2N8O4 |
| Molecular Weight | 691.61 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 20.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1982 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 8 |
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
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- Cabotegravir Impurity 9 (CAS CATO-C4X-28769)
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