Itraconazole EP Impurity B CAS 854372-77-3
| CAS No. | 854372-77-3 |
| Molecular Formula | 2*C35H38Cl2N8O4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Itraconazole EP Impurity B.
As a process- or degradation-related impurity, Itraconazole EP Impurity B (CAS 854372-77-3, C35H38Cl2N8O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Itraconazole EP Impurity B (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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
CATO manufactures Itraconazole EP Impurity B under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
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.) | 1987 |
| 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
- Cyanocobalamin /Vitamin B12 Impurity 36 (CAS CATO-C4X-187436)
- Ubrogepant Impurity 27 (CAS CATO-C4X-340227)
- CAS 2019119-44-7 (CAS 2019119-44-7)
- 4-(3-Bromopropyl)-2-methylthiophene (CAS 1093173-58-0)
- [3-(methoxymethoxy)-1-naphthyl]boronic acid (CAS 2766628-35-5)
- 8-cyclopropyl-3-oxa-8-azabicyclo[3.2.1]octane-2,4-dione (CAS 2031259-24-0)
- tert-Butyl 2,7-diazaspiro[4.5]decane-2-carboxylate oxalate(2:1) (CAS 1523606-54-3)
- 2-(4-Bromo-2-fluorophenyl)-1,2-dihydro-5-methyl-3H-1,2,4-triazol-3-one (CAS 111992-09-7)
- 4-Nitro-N-phenylbenzo[c][1,2,5]oxadiazol-5-amine (CAS 18378-16-0)
- (Des-His1,Glu?)-Glucagon (1-29) amide (human, rat, porcine) (CAS 110084-95-2)
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