| CAS No. | 1297538-27-2 |
| Molecular Formula | C19H17ClN6O2 |
| Molecular Weight | 396.83 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 396.83 g/mol gives Darolutamide Impurity 27 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Darolutamide Impurity 27 (CAS 1297538-27-2) is a certified pharmaceutical impurity reference standard with the molecular formula C19H17ClN6O2 and a molecular weight of 396.83 g/mol.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Darolutamide Impurity 27 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 396.83 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
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 | C19H17ClN6O2 |
| Molecular Weight | 396.83 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1990 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 6 |