Itraconazole EP Impurity E CAS 252964-65-1
| CAS No. | 252964-65-1 |
| Molecular Formula | 2*C35H38Cl2N8O4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 705.64 g/mol gives Itraconazole EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Itraconazole EP Impurity E (CAS 252964-65-1) is a certified pharmaceutical impurity reference standard with the molecular formula C35H38Cl2N8O4 and a molecular weight of 705.64 g/mol.
The molecular framework of Itraconazole EP Impurity E (C35H38Cl2N8O4) 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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), Itraconazole EP Impurity E 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 | 2*C35H38Cl2N8O4 |
| Molecular Weight | 705.64 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.) | 2025 |
| 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
- Furosemide Impurity 64 (CAS 116436-17-0)
- Resmetirom Impurity 36 (CAS CATO-C4X-291236)
- Gadoxetate Impurity 13 (CAS CATO-C4X-261813)
- 2-Amino-N-(3-chloro-2-methylphenyl)acetamide (CAS 887359-01-5)
- Esomeprazole Impurity 46 (CAS 143016-70-0)
- 5-(3,5-Dichlorophenyl)-5-oxovaleric acid (CAS 172168-00-2)
- 1-(m-Tolyl)-1H-pyrazol-4-amine (CAS 90914-86-6)
- (2R,3S,4S,5R,6S)-2-(hydroxymethyl)-6-(((2R,3S,4S,5R,6S)-3,4,5-trihydroxy-6-(4-nitrophenoxy)tetrahydro-2H-pyran-2-yl)methoxy)tetrahydro-2H-pyran-3,4,5-triol (CAS 335193-88-9)
- 2-Chloro-6-(1H-pyrazol-4-yl)pyridine (CAS 1934955-05-1)
- Tirzepatide Impurity 36 (CAS CATO-C4X-324036)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com