Dronedarone Impurity 53 CAS CATO-C4X-109253
| CAS No. | CATO-C4X-109253 |
| Molecular Formula | C31H44N2O6S |
| 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 53.
As a process- or degradation-related impurity, Dronedarone Impurity 53 (CAS CATO-C4X-109253, C31H44N2O6SHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Dronedarone Impurity 53 (C31H44N2O6SHCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 53 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 | C31H44N2O6S HCl |
| Molecular Weight | 609.22 g/mol |
| 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; 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 | 2 |
| Sulfur 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
- Semaglutide impurity 65 (CAS CATO-C4X-222665)
- Calcium Pantothenate EP Impurity G (CAS 2140-53-6)
- Esomeprazole Impurity 58 (CAS CATO-C4X-111258)
- Benzyl 3-((2-aminoethyl)(ethyl)amino)pyrrolidine-1-carboxylate (CAS 1353976-24-5)
- 4-Hydroxy-3-nitrobenzenesulfonic acid (CAS 616-85-3)
- Tert-butyl2-(p-tolylsulfonyloxymethyl)-6,7-dihydro-4h-pyrazolo[1,5-a]pyrazine-5-carboxylate (CAS 2306274-60-0)
- 4-[(2-chlorophenyl)methoxy]thiophene-2-carboxylic acid (CAS 1511303-44-8)
- 2,4-Dibromo-3,5-dichloroiodobenzene (CAS 1160574-27-5)
- 2-Bromo-5-(piperazin-1-yl)pyrazine (CAS 446286-90-4)
- Insulin Degludec Impurity 27 (CAS CATO-C4X-215727)
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