Betahistine impurity 35 CAS CATO-C4X-183835
| CAS No. | CATO-C4X-183835 |
| Molecular Formula | C15H20N3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Betahistine impurity 35 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Betahistine impurity 35 (CAS CATO-C4X-183835, C15H20N3HClCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Betahistine impurity 35 (C15H20N3HClCl) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 314.25 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 certified reference material (CRM), Betahistine impurity 35 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 | C15H20N3 3*HCl Cl |
| Molecular Weight | 314.25 g/mol |
| Appearance | Off-white to pale 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Betahistine Standards
- Betahistine EP Impurity A (CAS 100-69-6)
- Betahistine Impurity 01 DiHCl (CAS 101252-40-8)
- Betahistine EP Impurity B (CAS 103-74-2)
- Betahistine Impurity 12 (CAS 109-06-8)
- Betahistine impurity 41 (CAS 113985-59-4)
- Betahistine Impurity 45 (CAS 128225-22-9)
- Betahistine impurity 33 (CAS 13585-92-7)
- Betahistine Impurity 13 HCl (CAS 13585-92-7（free base）)
Recommended Standards
- Eravacycline impurity 35 (CAS CATO-C4X-293835)
- Rosuvastatin Impurity 102 (CAS CATO-C4X-1169102)
- Edaravone Impurity N4 (CAS 14575-62-3)
- 4-Decyne (CAS 2384-86-3)
- N-(2-methyl-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenyl)propionamide (CAS 2246585-68-0)
- 4'-AMINOBIPHENYL-3-OL (CAS 779341-20-7)
- ML-099 (CAS 496775-95-2)
- 2-(2-Iodo-1H-indol-1-yl)acetic acid (CAS 206196-81-8)
- 2-Ethylhexyl 2-hydroxypropanoate (CAS 6283-86-9)
- Semaglutide impurity 60 (CAS CATO-C4X-222660)
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