| CAS No. | CATO-C4X-101337 |
| Molecular Formula | C24H18F5NO3S2 |
| Molecular Weight | 527.53 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Bicalutamide Impurity 37.
As a process- or degradation-related impurity, Bicalutamide Impurity 37 (CAS CATO-C4X-101337, C24H18F5NO3S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution, Bicalutamide Impurity 37 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 527.53 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C24H18F5NO3S2 |
| Molecular Weight | 527.53 g/mol |
| Purity | 95% |
| 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 2 |