| CAS No. | CATO-C4X-101648 |
| Molecular Formula | C25H11F9N6 |
| Molecular Weight | 566.38 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 Enzalutamide Impurity 48.
As a process- or degradation-related impurity, Enzalutamide Impurity 48 (CAS CATO-C4X-101648, C25H11F9N6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Enzalutamide Impurity 48 (C25H11F9N6) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 19.0, corresponding to approximately 19 ring(s) or double-bond equivalent(s). With a molecular weight of 566.38 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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), Enzalutamide Impurity 48 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.
| Molecular Formula | C25H11F9N6 |
| Molecular Weight | 566.38 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| 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) | 19.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 6 |