Fluconazole EP Impurity I Bromide CAS 150168-54-0
| CAS No. | 150168-54-0 |
| Molecular Formula | C13H14F2N7O |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Fluconazole EP Impurity I Bromide (CAS 150168-54-0, C13H14F2N7OBr) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C13H14F2N7OBr, Fluconazole EP Impurity I Bromide contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 402.20 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Fluconazole EP Impurity I Bromide 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 | C13H14F2N7O Br |
| Molecular Weight | 402.20 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1999 |
| Halogen Content | F/Br-containing |
| Nitrogen Atoms | 7 |
Related Fluconazole Standards
- Fluconazole-d4 (CAS 1124197-58-5)
- Fluconazole EP Impurity F (CAS 118689-07-9)
- Fluconazole Impurity 48 (CAS 1222655-38-0)
- Fluconazole Impurity 58 (CAS 123091-15-6 (free base))
- Fluconazole Impurity 19 (CAS 1348664-75-4)
- Fluconazole β-D-glucuronide (CAS 136134-23-1)
- Fluconazole EP Impurity H (CAS 150194-52-8)
- Fluconazole Impurity 22 (CAS 154534-83-5)
Recommended Standards
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- Pomalidomide-PEG2-C2-azide (CAS 2271036-45-2)
- 1-(3-Bromo-4-iodophenyl)-2,2,2-trifluoroethan-1-one (CAS 2149598-84-3)
- 3-(4-Fluorophenyl)prop-2-en-1-ol (CAS 7361-55-9)
- 4-(1-Tetrazolyl)phenol (CAS 64001-11-2)
- 4-(3-Chloro-4-fluorophenyl)but-3-yn-2-amine (CAS 2027452-83-9)
- (23Z)-Δ5,23-Stigmastadienol (CAS 84621-35-2)
- Human glucagon CRS (CAS 9007-92-5)
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