Dronedarone Impurity 1 CAS 141644-91-9
| CAS No. | 141644-91-9 |
| Molecular Formula | C30H42N2O3 |
| Molecular Weight | 478.67 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 1.
CATO supplies Dronedarone Impurity 1 (CAS 141644-91-9), a pharmacopoeial impurity reference standard (molecular formula C30H42N2O3, MW 478.67 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Dronedarone Impurity 1 (C30H42N2O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 478.67 g/mol, it falls into the moderately-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.
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.
Physical & Chemical Properties
| Molecular Formula | C30H42N2O3 |
| Molecular Weight | 478.67 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1997 |
| Nitrogen Atoms | 2 |
Related Dronedarone Standards
- Dronedarone Impurity 16 (CAS CATO-C4X-109216)
- Dronedarone Impurity 37 (CAS CATO-C4X-109237)
- Dronedarone Impurity 29 (CAS CATO-C4X-109229)
- Dronedarone Impurity 26 (CAS CATO-C4X-109226)
- Dronedarone Impurity 20 (CAS CATO-C4X-109220)
- Dronedarone Impurity 43 (CAS CATO-C4X-109243)
- Dronedarone Impurity 92 (CAS 141626-35-9)
- Dronedarone Impurity 15 (CAS CATO-C4X-109215)
Recommended Standards
- Etioporphyrin III (CAS 26608-34-4)
- Bis(4-benzyl-5-(propylthio)-4H-1,2,4-triazol-3-yl)methane (CAS 62575-60-4)
- Etioporphyrin I (CAS 448-71-5)
- Bis(5-(propylthio)-4-(m-tolyl)-4H-1,2,4-triazol-3-yl)methane (CAS 62575-64-8)
- Olaparib Impurity 56 (CAS CATO-C4X-113556)
- Glibenclamide Impurity 7 (CAS 3438-16-2)
- Trelagliptin Impurity 67 (CAS CATO-C4X-104667)
- 4-ethoxyoxane-4-carboxylic acid (CAS 1250823-60-9)
- 2-(3-Nitrophenyl)quinazoline (CAS 154221-02-0)
- N-(1H-Indol-5-yl)acetamide (CAS 7145-71-3)
- (3S,4aS,8aS)-N-(tert-Butyl)decahydroisoquinoline-3-carboxamide, >98% (CAS 136465-81-1)
- tert-Butyl 5-amino-3-(1-(tert-butoxycarbonyl)piperidin-4-yl)-1H-indazole-1-carboxylate (CAS 2577379-42-9)
- Benzyl (S)-5-methyl-1,2,3-oxathiazolidine-3-carboxylate 2,2-dioxide (CAS 1489246-88-9)
- Insulin Degludec Impurity 10 (CAS CATO-C4X-215710)
Why CATO?
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- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com