| CAS No. | 23008-65-3 |
| Molecular Formula | C11H11NO3 |
| Molecular Weight | 205.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Zonisamide Impurity 15 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, Zonisamide Impurity 15 (CAS 23008-65-3, C11H11NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Zonisamide Impurity 15 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 205.21 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.
| Molecular Formula | C11H11NO3 |
| Molecular Weight | 205.21 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1963 |
| Nitrogen Atoms | 1 |