Dronedarone Impurity 31 CAS 2540665-66-3
| CAS No. | 2540665-66-3 |
| Molecular Formula | C20H19NO5 |
| Molecular Weight | 353.37 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Dronedarone Impurity 31 (CAS 2540665-66-3) is a certified pharmaceutical impurity reference standard with the molecular formula C20H19NO5 and a molecular weight of 353.37 g/mol.
The molecular framework of Dronedarone Impurity 31 (C20H19NO5) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
As a certified reference material (CRM), Dronedarone Impurity 31 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.
Physical & Chemical Properties
| Molecular Formula | C20H19NO5 |
| Molecular Weight | 353.37 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2001 |
| Nitrogen Atoms | 1 |
Related Dronedarone Standards
- Dronedarone Impurity 30 (CAS CATO-C4X-109230)
- Dronedarone Impurity 34 (CAS CATO-C4X-109234)
- Dronedarone Impurity 5 (CAS 141627-42-1)
- Dronedarone Impurity 95 (CAS CATO-C4X-109295)
- Dronedarone Impurity 3 (CAS 141645-16-1)
- Dronedarone Impurity 79 (CAS CATO-C4X-109279)
- Dronedarone Impurity 80 (CAS CATO-C4X-109280)
- Dronedarone Impurity 83 (CAS 856758-05-9)
Recommended Standards
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