| CAS No. | CATO-C4X-109239 |
| Molecular Formula | C37H56N3O5 |
| Molecular Weight | 622.86 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Structurally, Dronedarone Impurity 39 (C37H56N3O5) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 11.5, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 622.86 g/mol, it falls into the high-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.
CATO supplies Dronedarone Impurity 39 (CAS CATO-C4X-109239), a pharmacopoeial impurity reference standard (molecular formula C37H56N3O5, MW 622.86 g/mol) used for the identification and quantification of trace impurities in APIs.
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.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
| Molecular Formula | C37H56N3O5 |
| Molecular Weight | 622.86 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| 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 |
| Degree of Unsaturation (DBE) | 11.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 3 |