Fulvestrant impurity 50 CAS CATO-C4X-191750
| CAS No. | CATO-C4X-191750 |
| Molecular Formula | C31H47BrO3 |
| Molecular Weight | 547.61 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Fulvestrant impurity 50 (CAS CATO-C4X-191750, C31H47BrO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Fulvestrant impurity 50 (C31H47BrO3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, bromine substitution, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), 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.
As a certified reference material (CRM), Fulvestrant impurity 50 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 | C31H47BrO3 |
| Molecular Weight | 547.61 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Br-containing |
Related Fulvestrant Standards
- Fulvestrant impurity 49 (CAS CATO-C4X-191749)
- Fulvestrant impurity 51 (CAS CATO-C4X-191751)
- Fulvestrant impurity 56 (CAS CATO-C4X-191756)
- Fulvestrant impurity 47 (CAS CATO-C4X-191747)
- Fulvestrant Impurity 16 (CAS CATO-C4X-191716)
- Fulvestrant Impurity 17 (CAS CATO-C4X-191717)
- Fulvestrant Impurity 18 (CAS CATO-C4X-191718)
- Fulvestrant Impurity 20 (CAS CATO-C4X-191720)
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