Fluconazole Impurity 59 CAS CATO-C4X-101959
| CAS No. | CATO-C4X-101959 |
| Molecular Formula | C10H7F2N4O2 |
| Molecular Weight | 253.18 g/mol |
| 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 Fluconazole Impurity 59.
As a process- or degradation-related impurity, Fluconazole Impurity 59 (CAS CATO-C4X-101959, C10H7F2N4O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Fluconazole Impurity 59 (C10H7F2N4O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.5, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 253.18 g/mol, it falls into the medium-molecular-weight range. 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.
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 | C10H7F2N4O2 |
| Molecular Weight | 253.18 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, 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; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 8.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 4 |
Related Fluconazole Standards
- Fluconazole EP Impurity F (CAS 118689-07-9)
- Fluconazole EP Impurity F (R-Isomer) (CAS CATO-C4X-101964)
- Fluconazole Impurity 39 (CAS CATO-C4X-101939)
- Fluconazole EP Impurity G (R-Isomer) (CAS CATO-C4X-101965)
- Fluconazole Impurity 18 (CAS 383127-79-5)
- Fluconazole Impurity 28 (CAS CATO-C4X-101928)
- Fluconazole Impurity 29 (CAS CATO-C4X-101929)
- Fluconazole Impurity 40 (CAS 206050-23-9)
Recommended Standards
- 6-(1H-pyrrol-1-yl)-3-(trifluoromethyl)-[1,2,4]triazolo[4,3-b]pyridazine (CAS 343372-90-7)
- (3-Methoxy-4-nitrophenyl)divinylphosphine oxide (CAS 1197956-07-2)
- 5-Amino-2-(4-(trifluoromethyl)phenyl)oxazole-4-carbonitrile (CAS 260973-63-5)
- 3-Fluoro-N-(3,4,5-trifluorobenzylidene)aniline (CAS 1202493-05-7)
- Finerenone Impurity 218 (CAS CATO-C4X-2880218)
- Mirogabalin Impurity 43 (CAS CATO-C4X-292443)
- Baloxavir Impurity C149 (CAS 2136287-68-6)
- Lithium trihydroxy(4-(trifluoromethyl)pyridin-2-yl)borate (CAS 1393822-85-9)
- Afatinib Impurity 50 (CAS 2413212-25-4)
- N-Nitroso Hydroxychloroquine (CAS CATO-C4X-183563)
- (4-Bromobenzyl)(3,4-difluorophenyl)sulfane (CAS 1443302-70-2)
- Ethyl 2-bromo-6-(tert-butyl)-3-hydroxyisonicotinate (CAS 868047-75-0)
- N-Heptane (CAS 142-82-5)
- Tirzepatide Impurity 51 (CAS CATO-C4X-324051)
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