Fluconazole EP Impurity E CAS 86404-63-9
| CAS No. | 86404-63-9 |
| Molecular Formula | C10H7F2N3O |
| Molecular Weight | 223.18 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 223.18 g/mol gives Fluconazole EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Fluconazole EP Impurity E (CAS 86404-63-9, C10H7F2N3O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Fluconazole EP Impurity E is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 223.18 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
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 | C10H7F2N3O |
| Molecular Weight | 223.18 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1981 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Fluconazole Standards
- Fluconazole Impurity 41 (CAS CATO-C4X-101941)
- Fluconazole Impurity 46 (CAS 2013304-99-7)
- Fluconazole Impurity 12 (CAS 188416-33-3)
- Fluconazole Impurity 40 (CAS 206050-23-9)
- Fluconazole Impurity 28 (CAS CATO-C4X-101928)
- Fluconazole Impurity 29 (CAS CATO-C4X-101929)
- Fluconazole Impurity 18 (CAS 383127-79-5)
- Fluconazole EP Impurity C (CAS 514222-44-7)
Recommended Standards
- Apremilast impurity 11 (CAS 15371-06-9)
- β--Glucopyranosyl nitromethane (CAS 81846-60-8)
- N-Carboxymethylcarbonylanthranilic acid, 97% (CAS 53947-84-5)
- Ticagrelor Impurity 121 (CAS 378236-67-0)
- Ibuprofen EP Impurity J (CAS 65813-55-0)
- Palbociclib Impurity 88 (CAS 868591-58-6)
- Irbesartan impurity 40 (CAS CATO-C4X-166640)
- Cefazedone impurity 17 (CAS CATO-C4X-117117)
- 3-Methylthiazolidine-4-carboxylic acid hydrochloride (CAS 105087-82-9)
- Boc-Val-Pro-Arg-AMC (CAS 65147-04-8)
- 5,5-dimethyl-5H,6H,7H-thieno[3,2-b]pyran-7-one (CAS 129969-30-8)
- 3-(Dimethylamino)-6-fluorobenzo[4,5]imidazo[1,2-a]pyridine-4-carbonitrile (CAS 338773-88-9)
- Carbidopa Impurity 20 (CAS CATO-C4X-231020)
- Insulin Degludec Impurity 17 (CAS CATO-C4X-215717)
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