| CAS No. | 1250316-60-9 |
| Molecular Formula | C12H26ClN |
| Molecular Weight | 219.79 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Dronedarone Impurity 60 is closely related to chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Dronedarone Impurity 60 (CAS 1250316-60-9), a pharmacopoeial impurity reference standard (molecular formula C12H26ClN, MW 219.79 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to chlorine substitution, Dronedarone Impurity 60 is typically white to off-white low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 219.79 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
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.
| Molecular Formula | C12H26ClN |
| Molecular Weight | 219.79 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 0.0 |
| CAS Registry Year (est.) | 1990 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |