Varenicline Impurity 64 CAS CATO-C4X-196264
| CAS No. | CATO-C4X-196264 |
| Molecular Formula | C28H26N6O |
| Molecular Weight | 462.55 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Varenicline Impurity 64 (CAS CATO-C4X-196264, C28H26N6O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Varenicline Impurity 64 (C28H26N6O) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
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 | C28H26N6O |
| Molecular Weight | 462.55 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 19.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 6 |
Related Varenicline Standards
- Varenicline Carbamoyl-B-D-Glucuronide (CAS 535920-98-0)
- Varenicline Impurity 72 (CAS CATO-C4X-196272)
- Varenicline Impurity 33 (CAS CATO-C4X-196233)
- Varenicline Impurity 62 (CAS CATO-C4X-196262)
- Varenicline Impurity 67 (CAS CATO-C4X-196267)
- Varenicline Impurity 14 (CAS CATO-C4X-196214)
- Varenicline N-Glucoside (CAS 873302-31-9)
- Varenicline Impurity 50 (CAS CATO-C4X-196250)
Recommended Standards
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