| CAS No. | 1956-36-1 |
| Molecular Formula | C10H13NO3 |
| Molecular Weight | 195.22 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO supplies Apremilast Impurity 47 (CAS 1956-36-1), a pharmacopoeial impurity reference standard (molecular formula C10H13NO3, MW 195.22 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Apremilast Impurity 47 (C10H13NO3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 195.22 g/mol, it falls into the medium-molecular-weight range. 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.
As a certified reference material (CRM), Apremilast Impurity 47 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 | C10H13NO3 |
| Molecular Weight | 195.22 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | 97%+ |
| 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) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Nitrogen Atoms | 1 |