Dronedarone Impurity 32 CAS CATO-C4X-109232
| CAS No. | CATO-C4X-109232 |
| Molecular Formula | C19H16ClNO5 |
| Molecular Weight | 373.79 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 32.
Dronedarone Impurity 32 (CAS CATO-C4X-109232) is a certified pharmaceutical impurity reference standard with the molecular formula C19H16ClNO5 and a molecular weight of 373.79 g/mol.
The molecular framework of Dronedarone Impurity 32 (C19H16ClNO5) is characterized by a flavonoid core, an amide 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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C19H16ClNO5 |
| Molecular Weight | 373.79 g/mol |
| Appearance | Pale yellow to 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 methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Dronedarone Standards
- Dronedarone Impurity 33 (CAS CATO-C4X-109233)
- Dronedarone Impurity 95 (CAS CATO-C4X-109295)
- Dronedarone Impurity 94 (CAS CATO-C4X-109294)
- Dronedarone Impurity 14 (CAS 1278585-70-8)
- Dronedarone Impurity 30 (CAS CATO-C4X-109230)
- Dronedarone Impurity 31 (CAS 2540665-66-3)
- Dronedarone Impurity 34 (CAS CATO-C4X-109234)
- Dronedarone Impurity 5 (CAS 141627-42-1)
Recommended Standards
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- Tivozanib Impurity 28 (CAS CATO-C4X-340028)
- 1380572-57-5 5-Chloro-3-[(3,4,5-trimethoxy-benzylidene)-hydrazono]-1,3-dihydro-indol-2-one (CAS 1380572-57-5)
- Benidipine Impurity 50 (CAS CATO-C4X-112050)
- Amylmetacresol EP Impurity F (CAS 150033-77-5)
- Lusutrombopag Impurity 64 (CAS CATO-C4X-208464)
- 1-(2-Iodoethyl)-3,5-dimethoxybenzene (CAS 77118-80-0)
- Ethyl 6-(2,2,2-trifluoroethoxy)nicotinate (CAS 1263276-73-8)
- Tazobactam Impurity 44 (CAS 120701-86-2)
- 2,8-Diazaspiro[5.5]undecan-1-one hydrochloride (CAS 1181265-43-9)
- 4-[(1R)-1-amino-2-methoxyethyl]-benzonitrile (CAS 1269968-25-3)
- (2R,3S,5R)-2-((Bis(4-methoxyphenyl)(phenyl)methoxy)methyl)-5-(5-bromo-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)tetrahydrofuran-3-yl (2-cyanoethyl) diisopropylphosphoramidite (CAS 142246-64-8)
- Insulin aspart (CAS 116094-23-6)
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