Amiodarone EP Impurity B CAS 83409-32-9
| CAS No. | 83409-32-9 |
| Molecular Formula | C23H25I2NO3 |
| Molecular Weight | 617.26 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 Amiodarone EP Impurity B.
Amiodarone EP Impurity B (CAS 83409-32-9) is a certified pharmaceutical impurity reference standard with the molecular formula C23H25I2NO3 and a molecular weight of 617.26 g/mol.
The molecular framework of Amiodarone EP Impurity B (C23H25I2NO3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, iodine 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 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 | C23H25I2NO3 |
| Molecular Weight | 617.26 g/mol |
| Purity | >95% |
| Storage | Store at room temperature, 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1980 |
| Halogen Content | I-containing |
| Nitrogen Atoms | 1 |
Related Amiodarone Standards
- Amiodarone Impurity 19 (CAS 1346604-30-5)
- Amiodarone Impurity 20 (CAS CATO-C4X-142520)
- Amiodarone (CAS 1951-25-3)
- Amiodarone Impurity 16 (CAS 1391054-75-3)
- Amiodarone Impurity I (CAS CATO-C4X-142515)
- Amiodarone Impurity 45 (CAS CATO-C4X-142545)
- Amiodarone Didesethyl Impurity (CAS 94317-95-0)
- Amiodarone Impurity 16 (CAS 318267-30-0)
Recommended Standards
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- 4-n-Octylbenzoic acid (CAS 3575-31-3)
- 4-Chloro-6-(trifluoromethyl)-1,3-dihydro-2H-benzo[d]imidazole-2-thione (CAS 175135-18-9)
- 3,6-Bis(4-(tert-butyl)phenyl)-9H-carbazole (CAS 728904-28-7)
- 4-((4-(4-Methylpiperazin-1-yl)phenyl)amino)-4-oxobutanoic acid (CAS 724455-62-3)
- Anisole-Cycle-<SUP>13</SUP>C<SUB>6</SUB> (CAS 152571-52-3)
- (6-Hydroxynaphthalen-2-yl)(piperidin-1-yl)methanone (CAS 871121-70-9)
- Semaglutide impurity 62 (CAS CATO-C4X-222662)
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