| CAS No. | 138112-79-5 |
| Molecular Formula | C16H19NO2 |
| Molecular Weight | 257.33 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 257.33 g/mol gives Agomelatine Impurity 32 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
CATO supplies Agomelatine Impurity 32 (CAS 138112-79-5), a pharmacopoeial impurity reference standard (molecular formula C16H19NO2, MW 257.33 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Agomelatine Impurity 32 (C16H19NO2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 257.33 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), Agomelatine Impurity 32 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 | C16H19NO2 |
| Molecular Weight | 257.33 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1996 |
| Nitrogen Atoms | 1 |