Dronedarone Impurity 46 CAS CATO-C4X-109246
| CAS No. | CATO-C4X-109246 |
| Molecular Formula | C19H19NO3 |
| Molecular Weight | N/A |
| 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 46.
As a process- or degradation-related impurity, Dronedarone Impurity 46 (CAS CATO-C4X-109246, C19H19NO3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Dronedarone Impurity 46 (C19H19NO3HCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
CATO manufactures Dronedarone Impurity 46 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
Physical & Chemical Properties
| Molecular Formula | C19H19NO3 HCl |
| Molecular Weight | 345.82 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| 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
- Vazegepant Impurity 40 (CAS CATO-C4X-320040)
- Metronidazole EP Impurity F (CAS 16156-94-8)
- Esomeprazole impurity 03 (CAS 91168-31-9)
- [(1Z)-1-Methyl-1-propen-1-yl](triphenylphosphine)gold (CAS 917249-26-4)
- N-(2,5-Dichlorophenyl)-2-fluorobenzamide (CAS 313552-62-4)
- Ethyl 3-(2-Nitrophenyl)propanoate (CAS 66757-87-7)
- 3-((tert-Butoxycarbonyl)amino)hex-5-enoic acid (CAS 1335042-76-6)
- 2-(1-methyl-1H-imidazol-5-yl)acetic acid (CAS 4200-48-0)
- 3,5-Dichloro-1-phenethylpyrazin-2(1H)-one (CAS 138610-68-1)
- 302798-54-5 (Leu31,Pro34)-Neuropeptide Y (13-36) (human, rat) MFCD00672463 (CAS 302798-54-5)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com