Azelastine Impurity 13 CAS 791758-74-2
| CAS No. | 791758-74-2 |
| Molecular Formula | C15H19N3O2 |
| Molecular Weight | 273.33 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 Azelastine Impurity 13.
Azelastine Impurity 13 (CAS 791758-74-2) is a certified pharmaceutical impurity reference standard with the molecular formula C15H19N3O2 and a molecular weight of 273.33 g/mol.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Azelastine Impurity 13 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 273.33 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C15H19N3O2 |
| Molecular Weight | 273.33 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >80% |
| 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 |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1986 |
| Nitrogen Atoms | 3 |
Related Azelastine Standards
- Azelastine Impurity 67 (CAS CATO-C4X-139667)
- Azelastine Impurity 68 (CAS CATO-C4X-139668)
- Azelastine Hydrochloride EP Impurity C (CAS 53242-76-5)
- Azelastine Impurity 45 (CAS 148960-78-5)
- Azelastine Impurity 47 (CAS CATO-C4X-139647)
- Azelastine EP Impurity D (CAS 53242-88-9)
- Azelastine impurity 58 (CAS CATO-C4X-139658)
- Azelastine EP Impurity E (Z-Isomer) (CAS 105279-16-1)
Recommended Standards
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