Miconazole EP Impurity E CAS CATO-C4X-180228
| CAS No. | CATO-C4X-180228 |
| Molecular Formula | C22H20Cl4N2O3 |
| Molecular Weight | 502.22 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Miconazole EP Impurity E (CAS CATO-C4X-180228, C22H20Cl4N2O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Miconazole EP Impurity E (C22H20Cl4N2O3) is characterized by a steroid core, 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
Physical & Chemical Properties
| Molecular Formula | C22H20Cl4N2O3 |
| Molecular Weight | 502.22 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Miconazole Standards
- Miconazole impurity 34 (CAS CATO-C4X-180234)
- Miconazole EP Impurity D (CAS 27523-40-6)
- Miconazole EP Impurity F (CAS 47447-55-2)
- Miconazole EP Impurity G (CAS 909277-71-0)
- Miconazole (CAS 22916-47-8)
- Miconazole Impurity N1 (CAS 911805-54-4)
- Miconazole Impurity 15 (CAS 913837-72-6)
- Miconazole EP Impurity I (CAS 47363-37-1)
Recommended Standards
- 4-(5-((4-Bromobenzyl)thio)-4-(4-bromophenyl)-4H-1,2,4-triazol-3-yl)pyridine (CAS 477329-65-0)
- 10,10'-Oxybis(phenoxarsine) (CAS 58-36-6)
- 4-(5-((3-Bromobenzyl)thio)-4-(4-bromophenyl)-4H-1,2,4-triazol-3-yl)pyridine (CAS 618432-42-1)
- 2-(2-Fluoropropan-2-yl)-5-(tributylstannyl)-4-(trifluoromethyl)thiazole (CAS 2806011-98-1)
- Peptide Impurity (CAS CATO-CPTD788810)
- Lansoprazole Impurity 34 (CAS 1357726-93-2)
- Verapamil Impurity 35 HCl (CAS 77326-93-3 (free base))
- 6-Hydroxy-8-methyl-8-azabicyclo[3.2.1]Octan-3-one (CAS 110061-26-2)
- Brometazepam (CAS 84031-17-4)
- 6-Bromo-4-hydroxy-2H-chromen-2-one (CAS 4139-61-1)
- Benzyl 5,6-dihydroxy-1H-indole-2-carboxylate (CAS 113934-61-5)
- Itraconazole Impurity 93 (CAS 110762-98-6)
- Sodium Bis(nonafluorobutanesulfonyl)imide (CAS 129135-86-0)
- D-Ala21-Tirzepatide (CAS CATO-CPTD788913)
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