| CAS No. | 5434-20-8 |
| Molecular Formula | C8H7NO4 |
| Molecular Weight | 181.15 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Apremilast Impurity 67 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.
CATO supplies Apremilast Impurity 67 (CAS 5434-20-8), a pharmacopoeial impurity reference standard (molecular formula C8H7NO4, MW 181.15 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Apremilast Impurity 67 (C8H7NO4) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 181.15 g/mol, it falls into the medium-molecular-weight range. 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.
| Molecular Formula | C8H7NO4 |
| Molecular Weight | 181.15 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1958 |
| Nitrogen Atoms | 1 |