| CAS No. | 55362-80-6 |
| Molecular Formula | C9H19BrO |
| Molecular Weight | 223.15 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a process- or degradation-related impurity, Fulvestrant Impurity 9 (CAS 55362-80-6, C9H19BrO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C9H19BrO, Fulvestrant Impurity 9 contains a hydroxyl group, an ether linkage, bromine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 223.15 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
| Molecular Formula | C9H19BrO |
| Molecular Weight | 223.15 g/mol |
| Purity | >95% |
| Storage | Store at room temperature, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Stable under recommended storage conditions |
| Degree of Unsaturation (DBE) | 0.0 |
| CAS Registry Year (est.) | 1972 |
| Halogen Content | Br-containing |