Levocabastine EP Impurity C CAS CATO-C4X-22893
| CAS No. | CATO-C4X-22893 |
| Molecular Formula | C26H29FN2O2 |
| Molecular Weight | 420.52 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Levocabastine EP Impurity C is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Levocabastine EP Impurity C (CAS CATO-C4X-22893, C26H29FN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Levocabastine EP Impurity C (C26H29FN2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 420.52 g/mol, it falls into the moderately-high-molecular-weight range. 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.
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 | C26H29FN2O2 |
| Molecular Weight | 420.52 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 (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 E (CAS CATO-C4X-22895)
- Levocabastine EP Impurity I (CAS CATO-C4X-22899)
- Levocabastine EP Impurity D (CAS CATO-C4X-22894)
- Levocabastine EP Impurity J (CAS CATO-C4X-228910)
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