Darolutamide impurity 5 CAS CATO-C4X-31065
| CAS No. | CATO-C4X-31065 |
| Molecular Formula | C19H21ClN6O3 |
| Molecular Weight | 416.86 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Darolutamide impurity 5 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.
As a process- or degradation-related impurity, Darolutamide impurity 5 (CAS CATO-C4X-31065, C19H21ClN6O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Darolutamide impurity 5 (C19H21ClN6O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
Physical & Chemical Properties
| Molecular Formula | C19H21ClN6O3 |
| Molecular Weight | 416.86 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 6 |
Related Darolutamide Standards
- Darolutamide Impurity 21 (CAS CATO-C4X-310621)
- Darolutamide Impurity 18 (CAS CATO-C4X-310618)
- Darolutamide impurity 7 (CAS CATO-C4X-31067)
- Darolutamide Impurity 34 (CAS CATO-C4X-310634)
- Darolutamide Impurity 28 (CAS CATO-C4X-310628)
- Darolutamide D4 (CAS 2484757-19-7)
- Darolutamide Impurity 17 (CAS CATO-C4X-310617)
- Darolutamide (CAS 1297538-32-9)
Recommended Standards
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