Terbinafine EP Impurity B CAS 78628-81-6
| CAS No. | 78628-81-6 |
| Molecular Formula | C21H25N |
| Molecular Weight | 291.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Terbinafine EP Impurity B (CAS 78628-81-6, C21H25N) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Terbinafine EP Impurity B (C21H25N) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 EP Impurity B 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 | C21H25N |
| Molecular Weight | 291.43 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1979 |
| Nitrogen Atoms | 1 |
Related Terbinafine Standards
- Terbinafine EP Impurity C (CAS 187540-01-8)
- Terbinafine Impurity 51 (CAS CATO-C4X-133851)
- Terbinafine Impurity 52 (CAS 2416665-26-2)
- Terbinafine (CAS 91161-71-6)
- Terbinafine lmpurity 36 (CAS CATO-C4X-133836)
- Terbinafine EP Impurity D (CAS 151222-50-3)
- Terbinafine Impurity 31 (CAS CATO-C4X-133831)
- Terbinafine impurity 34 (CAS CATO-C4X-133834)
Recommended Standards
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- rel-((3R,6R)-1-tert-butyl 3-methyl 6-methylpiperidine-1,3-dicarboxylate) (CAS 1009376-75-3)
- 3-(5-Chloro-6-(trifluoromethyl)pyridin-2-yl)propan-1-amine (CAS 1393546-84-3)
- 2-Amino-1-(2-((benzyl(cyclopropyl)amino)methyl)piperidin-1-yl)ethanone (CAS 1353975-97-9)
- 3,5-Dimethyl-4-methoxybenzoic Acid (CAS 21553-46-8)
- Ethyl 3-amino-5-fluoropicolinate (CAS 1804170-93-1)
- Pantoprazole Isomer(R) Impurity (CAS 142706-18-1)
- Semaglutide Impurity 2 (CAS CATO-C4X-22262)
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