Epinastine EP Impurity B(Hydrochloride) CAS CATO-C4X-18402
| CAS No. | CATO-C4X-18402 |
| Molecular Formula | C16H14BrN3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Epinastine EP Impurity B(Hydrochloride) (CAS CATO-C4X-18402, C16H14BrN3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Epinastine EP Impurity B(Hydrochloride) (C16H14BrN3HCl) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine/bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 364.67 g/mol, it falls into the moderately-high-molecular-weight range. 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 certified reference material (CRM), Epinastine EP Impurity B(Hydrochloride) 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.
Physical & Chemical Properties
| Molecular Formula | C16H14BrN3 HCl |
| Molecular Weight | 364.67 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl/Br-containing |
| Nitrogen Atoms | 3 |
Related Epinastine Standards
- Epinastine Impurity 24 (CAS 1110929-19-5)
- Epinastine Impurity 53 (CAS 114-39-6)
- Epinastine Related Compound A HCl (CAS 1159604-26-8)
- Epinastine Impurity 6 (CAS 1211-06-9)
- Epinastine Impurity 3 (CAS 1216548-20-7)
- Epinastine EP Impurity B (CAS 1217052-16-8)
- Epinastine Impurity 22 (CAS 124847-00-3)
- Epinastine Impurity 44 Fumarate (CAS 127785-96-0)
Recommended Standards
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- 2-Bromo-4-methylheptane (CAS 61764-96-3)
- (2R)-2-amino-3-(1-bicyclo[1.1.1]pentanyl)propanoic acid (CAS 2200552-04-9)
- methyl 1,3-dimethyl-4-nitro-1H-pyrazole-5-carboxylate (CAS 78208-69-2)
- 2-Bromo-5-cyclopentyl-1H-imidazole (CAS 1785213-99-1)
- 3-Amino-8-((2-amino-1,6-dimethylpyrimidin-4(1H)-ylidene)amino)-6-(4-aminophenyl)-5-methylphenanthridin-5-ium bromide hydrobromide (CAS 14222-46-9)
- 8-Hydroxyimidazo[1,2-a]pyridine-3-carbaldehyde (CAS 1033202-04-8)
- Semaglutide Impurity 12 (CAS CATO-C4X-222612)
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