Rabeprazole Impurity N4 CAS 2514958-53-1
| CAS No. | 2514958-53-1 |
| Molecular Formula | C10H13Cl2NO |
| 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, Rabeprazole Impurity N4 (CAS 2514958-53-1, C10H13Cl2NOHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Rabeprazole Impurity N4 (C10H13Cl2NOHCl) contains an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C10H13Cl2NO HCl |
| Molecular Weight | 270.58 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 2000 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Rabeprazole Standards
- Rabeprazole EP Impurity E (CAS 102804-77-3)
- Rabeprazole EP Impurity G (CAS 102804-82-0)
- Rabeprazole Impurity 9 (CAS 1114543-47-3)
- Rabeprazole 4-Chloro Analog Sulfone (CAS 1159977-27-1)
- Rabeprazole Impurity N1 (CAS 1163685-30-0)
- Rabeprazole Impurity 29 (CAS 1163685-31-1)
- Rabeprazole EP Impurity A (CAS 117976-47-3)
- Rabeprazole (CAS 117976-89-3)
Recommended Standards
- Prostaglandin Impurity 15 (CAS 5307-99-3)
- Fluphenazine Decanoate EP Impurity C DiHCl (CAS 3105-68-8)
- Pitavastatin Impurity 45 (CAS CATO-C4X-103745)
- N-(4-Amino-2-methylphenyl)methanesulfonamide (CAS 57165-01-2)
- 5-Methoxy-3-nitro-1,2-benzenediamine (CAS 76179-57-2)
- 5-Methyl-5-nitrohexan-2-one (CAS 4604-49-3)
- 2-Chloro-6-fluorothiazolo[4,5-b]pyridine (CAS 1190927-28-6)
- 2,3-Dimethylimidazo[2,1-b][1,3]thiazole-6-carboxylic acid (CAS 57333-49-0)
- N-(5-(p-Tolyl)-1,3,4-thiadiazol-2-yl)butyramide (CAS 303064-08-6)
- Acetyl Tetrapeptide- 15 (CAS 928007-64-1)
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