| CAS No. | 101252-40-8 |
| Molecular Formula | C8H12N2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Betahistine Impurity 01 DiHCl 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.
As a process- or degradation-related impurity, Betahistine Impurity 01 DiHCl (CAS 101252-40-8, C8H12N2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Betahistine Impurity 01 DiHCl (C8H12N2HCl) contains a nitrile group, chlorine substitution. Halogen substitution raises its density and boiling point; 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).
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.
| Molecular Formula | C8H12N2 2*HCl |
| Molecular Weight | 172.66 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| 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) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1985 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |