Amiodarone EP Impurity G(HCl) CAS CATO-C4X-14257
| CAS No. | CATO-C4X-14257 |
| Molecular Formula | C26H31I2NO4 |
| 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 EP Impurity G(HCl).
Amiodarone EP Impurity G(HCl) (CAS CATO-C4X-14257) is a certified pharmaceutical impurity reference standard with the molecular formula C26H31I2NO4HCl and a molecular weight of 711.80 g/mol.
The molecular framework of Amiodarone EP Impurity G(HCl) (C26H31I2NO4HCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine/iodine 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 | C26H31I2NO4 HCl |
| Molecular Weight | 711.80 g/mol |
| Purity | >95% |
| Storage | Store at room temperature, 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) | 10.0 |
| 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)
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- Poly(3-hexylthiophene) (CAS 104934-50-1)
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