| CAS No. | CATO-C4X-322816 |
| Molecular Formula | C11H16ClN3O2 |
| Molecular Weight | 257.72 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Enarodustat Impurity 16 (CAS CATO-C4X-322816) is a certified pharmaceutical impurity reference standard with the molecular formula C11H16ClN3O2 and a molecular weight of 257.72 g/mol.
Enarodustat Impurity 16 (C11H16ClN3O2) contains a nitrogen-containing heterocyclic scaffold, 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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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), Enarodustat Impurity 16 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 | C11H16ClN3O2 |
| Molecular Weight | 257.72 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 0.95 |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| 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) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |