Levocabastine EP Impurity D CAS CATO-C4X-22894
| CAS No. | CATO-C4X-22894 |
| Molecular Formula | C25H27FN2O2 |
| Molecular Weight | 406.49 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Levocabastine EP Impurity D (C25H27FN2O2) 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. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
As a process- or degradation-related impurity, Levocabastine EP Impurity D (CAS CATO-C4X-22894, C25H27FN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 | C25H27FN2O2 |
| Molecular Weight | 406.49 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Levocabastine Standards
- Levocabastine EP Impurity A (CAS CATO-C4X-22891)
- Levocabastine (CAS 79516-68-0)
- Levocabastine EP Impurity B (CAS CATO-C4X-22892)
- Levocabastine Hydrochloride EP Impurity I (CAS CATO-C4X-228925)
- Levocabastine EP impurity E (CAS 105452-51-5)
- Levocabastine EP Impurity C (CAS CATO-C4X-22893)
- Levocabastine EP Impurity E (CAS CATO-C4X-22895)
- Levocabastine EP Impurity I (CAS CATO-C4X-22899)
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