Bepotastine Impurity 8 CAS CATO-C4X-18398
| CAS No. | CATO-C4X-18398 |
| Molecular Formula | C27H35ClN2O5 |
| Molecular Weight | 503.03 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Bepotastine Impurity 8 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Bepotastine Impurity 8 (CAS CATO-C4X-18398) is a certified pharmaceutical impurity reference standard with the molecular formula C27H35ClN2O5 and a molecular weight of 503.03 g/mol.
Structurally, Bepotastine Impurity 8 (C27H35ClN2O5) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 503.03 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.
Physical & Chemical Properties
| Molecular Formula | C27H35ClN2O5 |
| Molecular Weight | 503.03 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Bepotastine Standards
- Bepotastine Impurity 9 (CAS CATO-C4X-18399)
- Bepotastine Impurity 15 (CAS CATO-C4X-183915)
- Bepotastine Impurity 22 (CAS CATO-C4X-183922)
- Bepotastine Impurity 16 (CAS CATO-C4X-183916)
- Bepotastine Impurity 24 (CAS 1807607-93-7)
- Bepotastine Ethyl Ester (CAS 190730-39-3)
- Bepotastine N-Oxide Impurity (CAS CATO-C4X-18391)
- Bepotastine Impurity 10 (CAS CATO-C4X-183910)
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