Sotalol EP Impurity B HCl CAS 5576-49-8
| CAS No. | 5576-49-8 |
| Molecular Formula | C12H18N2O3S |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Sotalol EP Impurity B HCl (CAS 5576-49-8) is a certified pharmaceutical impurity reference standard with the molecular formula C12H18N2O3SHCl and a molecular weight of 306.81 g/mol.
Sotalol EP Impurity B HCl (C12H18N2O3SHCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, 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. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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), Sotalol EP Impurity B 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 | C12H18N2O3S HCl |
| Molecular Weight | 306.81 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1958 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
| Sulfur Atoms | 1 |
Related Sotalol Standards
Recommended Standards
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- Vonoprazan Impurity 57 (CAS 2726830-13-1)
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- (S)-1-Boc-N-methoxy-N-methylpiperidine-3-carboxamide (CAS 1008562-93-3)
- 4-Methyl-2(5H)-furanone (CAS 6124-79-4)
- 4-Ethyl-1-methyl-3-(tetrahydro-2h-pyran-3-yl)-1h-pyrazol-5-amine (CAS 1340373-57-0)
- 1-Methyl-3-(4-(trifluoromethoxy)phenyl)-1H-pyrazol-5-amine (CAS 1019011-55-2)
- Cytarabine Impurity 14 (CAS 3768-18-1)
- (4-Bromo-5-(difluoromethyl)-2-iodopyridin-3-yl)methanol (CAS 1805246-88-1)
- Semaglutide Impurity 167 (CAS CATO-C4X-2226167)
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