Dronedarone Impurity 61 CAS 1343091-70-2
| CAS No. | 1343091-70-2 |
| Molecular Formula | C10H22ClN |
| Molecular Weight | 191.74 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dronedarone Impurity 61.
Dronedarone Impurity 61 (CAS 1343091-70-2) is a certified pharmaceutical impurity reference standard with the molecular formula C10H22ClN and a molecular weight of 191.74 g/mol.
Owing to chlorine substitution, Dronedarone Impurity 61 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 191.74 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 61 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 | C10H22ClN |
| Molecular Weight | 191.74 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 0.0 |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Dronedarone Standards
- Dronedarone Impurity 59 (CAS 13422-90-7)
- Dronedarone Impurity 62 (CAS 5511-89-7)
- Dronedarone Impurity 73 (CAS 5337-04-2)
- Dronedarone Impurity 75 (CAS 2003093-69-2)
- Dronedarone Impurity 55 (CAS 100-07-2)
- Dronedarone Impurity 45 (CAS 133238-87-6)
- Dronedarone Impurity 60 (CAS 1250316-60-9)
- Dronedarone Impurity 74 (CAS 948015-51-8)
Recommended Standards
- (4,6-Dichloropyridine-3yl)boronic acid (CAS 1070893-11-6)
- Rosuvastatin Impurity 197 (CAS 727382-14-1)
- 5,6-Dichloropyridine-3-boronic Acid (CAS 1072944-15-0)
- 4-Chloro-3-((trimethylsilyl)oxy)butanenitrile (CAS 81091-27-2)
- Moxifloxacin Impurity 12 (CAS 112811-72-0)
- Darolutamide Impurity 36 (CAS CATO-C4X-310636)
- Limaprost Impurity 15 (CAS CATO-C4X-214515)
- 4-(Aminomethyl)-2-methylpyrimidine (CAS 22454-79-1)
- 1-Bromo-2,5-dichloro-3-methoxybenzene (CAS 174913-17-8)
- Silver(II) Pyridine-2-carboxylate (CAS 14783-00-7)
- 2-Bromo-4-(tert-pentyl)phenyl 3-pyrrolidinylether hydrochloride (CAS 1220019-18-0)
- (E)-1-((3-chloro-5-(trifluoromethyl)pyridin-2-yl)(methyl)amino)-5-(3-(dimethylamino)acryloyl)-3-(4-fluorobenzyl)pyrimidine-2,4(1H,3H)-dione (CAS 338399-45-4)
- Platinum, [1-[[3-[(2-aminoethyl)amino]propyl]amino]-9,10-anthracenedione]dichloro (CAS 131041-28-6)
- Peptide 438 (CAS CATO-CPTD788438)
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