Amiodarone Impurity HCl CAS CATO-C4X-142546
| CAS No. | CATO-C4X-142546 |
| Molecular Formula | C20H23I2NO2 |
| 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 Amiodarone Impurity HCl.
Amiodarone Impurity HCl (CAS CATO-C4X-142546) is a certified pharmaceutical impurity reference standard with the molecular formula C20H23I2NO2HCl and a molecular weight of 599.67 g/mol.
Based on its molecular formula C20H23I2NO2HCl, Amiodarone Impurity HCl contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine/iodine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 599.67 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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), Amiodarone Impurity HCl 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 | C20H23I2NO2 HCl |
| Molecular Weight | 599.67 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at room temperature, protect from light |
| 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl/I-containing |
| Nitrogen Atoms | 1 |
Related Amiodarone Standards
- Amiodarone EP Impurity H (CAS 100-35-6)
- Amiodarone EP Impurity G (CAS 1087223-70-8)
- Amiodarone EP Impurity B D4 HCl (CAS 1189960-80-2)
- Amiodarone-D4 Hydrochloride (CAS 1216715-80-8)
- Amiodarone D4 (CAS 1217169-60-2)
- Amiodarone Impurity 32 (CAS 134-92-9)
- Amiodarone Impurity 19 (CAS 1346604-30-5)
- Amiodarone Impurity 38 (CAS 138320-26-0)
Recommended Standards
- Papaverine impurity 21 (CAS CATO-C4X-206721)
- Glycyrrhizic Acid Impurity 13 (CAS CATO-C4X-253713)
- Bilastine impurity 134 (CAS CATO-C4X-2253134)
- Methyl 4-cyanofuran-2-carboxylate (CAS 357289-65-7)
- 1-(4-Fluorophenyl)-2-methyl-1-propanamine (CAS 863668-04-6)
- 3-Methyl-1-(2,2,2-trifluoroethyl)-1h-pyrazole-4-carbaldehyde (CAS 1006471-12-0)
- (S)-2-(2,6-difluorophenyl)pyrrolidine (CAS 1217833-86-7)
- 5-Cyclopentylthiazol-2-amine (CAS 851233-57-3)
- 2-Methyl-5-[(4-methylpiperidin-1-yl)sulfonyl]benzoic acid (CAS 637320-92-4)
- Cycloaspeptide A (CAS 109171-13-3)
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