Desloratadine EP Impurity B CAS 183198-49-4
| CAS No. | 183198-49-4 |
| Molecular Formula | C19H19ClN2 |
| Molecular Weight | 310.82 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Desloratadine EP Impurity B (CAS 183198-49-4, C19H19ClN2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution, Desloratadine EP Impurity B is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 310.82 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C19H19ClN2 |
| Molecular Weight | 310.82 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2009 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Desloratadine Standards
- Desloratadine Impurity 21 (CAS 1346600-61-0)
- Desloratadine Impurity N3 (CAS 1346601-53-3)
- Desloratadine-d4 (CAS 381727-29-3)
- Desloratadine-d5 (CAS 1020719-34-9)
- Desloratadine-d7 (major) (CAS 1795024-82-6)
- Desloratadine Impurity 24 (CAS CATO-C4X-143024)
- Desloratadine Impurity 25 (CAS CATO-C4X-143025)
- Desloratadine Impurity 30 (CAS 183198-48-3)
Recommended Standards
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- Rupatadine Impurity 36 (CAS 169253-15-0)
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