Itraconazole EP Impurity F CAS 89848-51-1
| CAS No. | 89848-51-1 |
| Molecular Formula | C35H38Cl2N8O4 |
| Molecular Weight | 705.63 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Itraconazole EP Impurity F (CAS 89848-51-1) is a certified pharmaceutical impurity reference standard with the molecular formula C35H38Cl2N8O4 and a molecular weight of 705.63 g/mol.
Based on its molecular formula C35H38Cl2N8O4, Itraconazole EP Impurity F contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 705.63 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).
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 | C35H38Cl2N8O4 |
| Molecular Weight | 705.63 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 24 (CAS CATO-C4X-149724)
- Itraconazole Impurity 86 (CAS CATO-C4X-149786)
- Itraconazole Impurity 90 (Mixture of Diastereomers) (CAS CATO-C4X-149790)
- Itraconazole (CAS 84625-61-6)
- Itraconazole-d3 (CAS 1217512-35-0)
- Itraconazole-d5(major) (CAS 1217510-38-7)
- Itraconazole-D9 (CAS 1309272-50-1)
- Itraconazole-d9 (CAS CATO-C4X-149751)
Recommended Standards
- 1-(Butan-2-yl)-4-{4-[4-(4-{[2-(2,4-dichlorophenyl)-2-[(1h-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1h-1,2,4-triazol-5-one (CAS 2049588-24-9)
- (2R,4S)-Itraconazole (Mixture of Diastereomers) (CAS 873066-43-4)
- Lifitegrast Impurity 22 (CAS CATO-C4X-240922)
- Blood Group A Tetrasaccharide (CAS 59957-92-5)
- Ibrutinib Impurity 96 (CAS CATO-C4X-106496)
- Folic Acid Impurity 55 (CAS CATO-C4X-139555)
- Azacitidine Impurity 83 (CAS CATO-C4X-138883)
- 3-((Piperidin-3-ylmethoxy)methyl)pyridine dihydrochloride (CAS 1185313-80-7)
- Tert-butyl 4-(((4-fluorophenyl)sulfonyl)methyl)piperidine-1-carboxylate (CAS 333988-27-5)
- 3,4,5-Trimethoxy-d9-2'-cyano-di-hydrocinnamaldehyde Dimethylacetal (CAS 1185144-63-1)
- methyl 6-chloro-4-methoxy-2-naphthoate (CAS 92023-33-1)
- 1,2,2,2-Tetrafluoroethanesulfonyl Fluoride (CAS 2127-74-4)
- 1-(2-Chloro-6-fluorophenyl)-2,2,2-trifluoroethan-1-ol (CAS 1249544-27-1)
- Semaglutide Impurity 246 (CAS CATO-C4X-2226246)
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