Dronedarone Impurity 25 CAS 437651-44-0
| CAS No. | 437651-44-0 |
| Molecular Formula | C18H29NO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO supplies Dronedarone Impurity 25 (CAS 437651-44-0), a pharmacopoeial impurity reference standard (molecular formula C18H29NO3HCl, MW 343.89 g/mol) used for the identification and quantification of trace impurities in APIs.
Dronedarone Impurity 25 (C18H29NO3HCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Dronedarone Impurity 25 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 | C18H29NO3 HCl |
| Molecular Weight | 343.89 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Dronedarone Standards
- Dronedarone Impurity 55 (CAS 100-07-2)
- Dronedarone-D6 (CAS 1132693-87-8)
- Dronedarone Impurity 42 (CAS 113385-32-3)
- Dronedarone Impurity 60 (CAS 1250316-60-9)
- Dronedarone USP Related Compound C (CAS 1278585-68-4)
- Dronedarone Impurity 14 (CAS 1278585-70-8)
- Dronedarone EP Impurity B DiHCl (CAS 1309476-91-2)
- Dronedarone-d6 HCl (CAS 1329809-23-5)
Recommended Standards
- Irinotecan Impurity 65 (CAS CATO-C4X-166765)
- Resmetirom Impurity 27 (CAS CATO-C4X-291227)
- Olopatadine Impurity 74 (CAS 2519517-78-1)
- 2,2',4,4',5,5'-Hexachloro-3-biphenylol (CAS 54284-55-8)
- Ethyl 5-(1-hydroxyethyl)-3-phenylisoxazole-4-carboxylate (CAS 95104-45-3)
- Methyl 1-benzyl-4-oxopiperidine-2-carboxylate (CAS 1218123-57-9)
- N-(1-Cyclohexylpyrrolidin-3-yl)-1-naphthamide (CAS 60691-46-5)
- 9,10-Dibromo-3-(3-chloro-5-(trifluoromethyl)pyridin-2-yl)-7,12-dioxa-3-azaspiro[5.6]Dodecane (CAS 337920-36-2)
- 2-Methoxybenzyl quinoline-1(2H)-carboxylate (CAS 30831-75-5)
- Peptide 431 (CAS CATO-CPTD788431)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com