Dronedarone EP Impurity B DiHCl CAS 1309476-91-2
| CAS No. | 1309476-91-2 |
| Molecular Formula | C30H42N2O3 |
| 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 Dronedarone EP Impurity B DiHCl.
As a process- or degradation-related impurity, Dronedarone EP Impurity B DiHCl (CAS 1309476-91-2, C30H42N2O3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Dronedarone EP Impurity B DiHCl is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 515.13 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.
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
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 | C30H42N2O3 2*HCl |
| Molecular Weight | 515.13 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1990 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Dronedarone Standards
- Dronedarone Impurity 55 (CAS 100-07-2)
- Dronedarone-D6 (CAS 1132693-87-8)
- Dronedarone Impurity 42 (CAS 113385-32-3)
- Dronedarone Impurity 60 (CAS 1250316-60-9)
- Dronedarone USP Related Compound C (CAS 1278585-68-4)
- Dronedarone Impurity 14 (CAS 1278585-70-8)
- Dronedarone-d6 HCl (CAS 1329809-23-5)
- Dronedarone Impurity 45 (CAS 133238-87-6)
Recommended Standards
- Linaclotide impurity 35 (CAS 1207977-38-5)
- Moxifloxacin Impurity 32 (CAS CATO-C4X-107432)
- Thiamazole impurity 9 (CAS CATO-C4X-20609)
- 7-Fluoro-3-methoxy-1H-indazole (CAS 1415741-96-6)
- (R)-1-(3,5-difluorophenyl)pentan-1-amine (CAS 1212817-78-1)
- trans-Methylkhellactone (CAS 23733-92-8)
- 1-(Octan-2-yl)-1H-pyrazol-4-amine (CAS 1240570-54-0)
- 6α-Hydroxy Prednisolone Acetate (CAS 134526-05-9)
- 2,5-Dichloro-1-methyl-3,6-dihydropyridin-4(1H)-one (CAS 1624262-49-2)
- Semaglutide impurity 34 (CAS CATO-C4X-222634)
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