Terbinafine Impurity N1 CAS 83554-69-2
| CAS No. | 83554-69-2 |
| Molecular Formula | C10H17N |
| Molecular Weight | 151.25 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Terbinafine Impurity N1 (CAS 83554-69-2, C10H17N) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Terbinafine Impurity N1 (C10H17N) contains a nitrile group. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 151.25 g/mol, it falls into the medium-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.
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), Terbinafine Impurity N1 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 | C10H17N |
| Molecular Weight | 151.25 g/mol |
| Appearance | White to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1980 |
| Nitrogen Atoms | 1 |
Related Terbinafine Standards
- Terbinafine lmpurity 28 (CAS 852616-90-1)
- Terbinafine Impurity 10 (CAS 126764-17-8)
- Terbinafine Impurity 9 (CAS 60845-51-4)
- Terbinafine Impurity 6 (CAS 36806-46-9)
- Terbinafine Impurity 43 (CAS CATO-C4X-133843)
- Terbinafine Impurity 4 (Mixture of Z and E Isomers) (CAS 114311-70-5)
- Terbinafine Impurity 15 (CAS 173200-56-1)
- Terbinafine Impurity 14 (CAS CATO-C4X-133814)
Recommended Standards
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