Amiodarone Impurity 28 CAS 318267-28-6
| CAS No. | 318267-28-6 |
| Molecular Formula | C25H30INO4 |
| Molecular Weight | 535.41 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 Impurity 28.
CATO supplies Amiodarone Impurity 28 (CAS 318267-28-6), a pharmacopoeial impurity reference standard (molecular formula C25H30INO4, MW 535.41 g/mol) used for the identification and quantification of trace impurities in APIs.
Amiodarone Impurity 28 (C25H30INO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 28 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 | C25H30INO4 |
| Molecular Weight | 535.41 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Halogen Content | I-containing |
| Nitrogen Atoms | 1 |
Related Amiodarone Standards
- Amiodarone Impurity 22 (CAS CATO-C4X-142522)
- Amiodarone Impurity 29 (CAS CATO-C4X-142529)
- Amiodarone Impurity 48 (CAS CATO-C4X-142548)
- Amiodarone EP Impurity D (CAS 1951-26-4)
- Amiodarone EP Impurity C (CAS 85642-08-6)
- Amiodarone Impurity 19 (CAS CATO-C4X-142519)
- Amiodarone Impurity 35 (CAS 149702-94-3)
- Amiodarone Impurity I (CAS CATO-C4X-142515)
Recommended Standards
- N-(2-Chloro-4-nitrophenyl)-2-((4-(4-chlorophenyl)-3-cyano-6-phenylpyridin-2-yl)thio)acetamide (CAS 332163-95-8)
- Mometasone Furoate EP Impurity F (CAS 1305334-30-8)
- 4-Bromo-N-((4-ethyl-5-((4-(trifluoromethyl)benzyl)thio)-4H-1,2,4-triazol-3-yl)methyl)benzenesulfonamide (CAS 338794-52-8)
- Methyl 2,3,4-Triacetyl-D-glucopyranosiduronyl 1-(N-4-Metoxyphenyl)-2,2,2-trifluoroacetimidate (CAS 918158-52-8)
- Ambroxol Impurity 54 (CAS CATO-C4X-108554)
- Crizotinib Impurity 49 (CAS CATO-C4X-102549)
- Clopidogrel Impurity 103 (CAS CATO-C4X-1029103)
- N-(3-chloro-4-methoxybenzyl)-4-(2-chlorophenyl)piperazine-1-carboxamide (CAS 866132-10-7)
- (R)-1-cyclohexyl-3-methylpiperazine (CAS 182141-99-7)
- 2-((4-Methylcyclohexyl)amino)propan-1-ol (CAS 1154899-95-2)
- tert-butyl 3-ethynyl-3-hydroxypiperidine-1-carboxylate (CAS 287192-85-2)
- 7-Bromo-4-chloroquinoline-3-carboxylic acid (CAS 1448260-56-7)
- 5-Phenyl-1,3,4-thiadiazole-2-sulfonyl fluoride (CAS 1334625-06-7)
- Cholecystokinin Octapeptide (1-5) (desulfated) (CAS 121880-96-4)
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