Azelastine Impurity 37 CAS CATO-C4X-139637
| CAS No. | CATO-C4X-139637 |
| Molecular Formula | C29H30FN3O |
| Molecular Weight | 455.57 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
CATO supplies Azelastine Impurity 37 (CAS CATO-C4X-139637), a pharmacopoeial impurity reference standard (molecular formula C29H30FN3O, MW 455.57 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Azelastine Impurity 37 (C29H30FN3O) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
Physical & Chemical Properties
| Molecular Formula | C29H30FN3O |
| Molecular Weight | 455.57 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at room temperature, 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) | 16.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Azelastine Standards
- Azelastine-13C,d3 N-Oxide (Mixture of Diastereomers) (CAS 1346602-76-3)
- (S)-Azelastine N-Oxide (Mixture of Diastereomers) (CAS 1346617-06-8)
- (R)-Azelastine N-Oxide (Mixture of Diastereomers) (CAS 1346617-18-2)
- Azelastine USP Related Compound F (CAS 640279-88-5)
- Azelastine impurity 66 (CAS CATO-C4X-139666)
- Azelastine Impurity 72 (CAS CATO-C4X-139672)
- Azelastine-d3 (CAS 758637-88-6)
- Azelastine-13C,d3 (CAS 1217019-80-1)
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