Varenicline Impurity 5 CAS 950781-89-2
| CAS No. | 950781-89-2 |
| Molecular Formula | C13H12F3N3O3 |
| Molecular Weight | 315.25 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Varenicline Impurity 5.
As a process- or degradation-related impurity, Varenicline Impurity 5 (CAS 950781-89-2, C13H12F3N3O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Varenicline Impurity 5 (C13H12F3N3O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 315.25 g/mol, it falls into the moderately-high-molecular-weight range. 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.
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 | C13H12F3N3O3 |
| Molecular Weight | 315.25 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Varenicline Standards
- Varenicline Impurity 35 (CAS CATO-C4X-196235)
- Varenicline Impurity 56 (CAS CATO-C4X-196256)
- Varenicline Impurity 18 (CAS 230615-70-0)
- Varenicline Impurity 55 (CAS CATO-C4X-196255)
- Varenicline Impurity 7 (CAS 357426-10-9)
- Varenicline Impurity 1 (CAS 230615-53-9)
- Varenicline Impurity 52 (CAS CATO-C4X-196252)
- Varenicline Impurity N22 (CAS 2759288-58-7)
Recommended Standards
- Vilanterol Impurity 65 (CAS 503068-31-3)
- Lusutrombopag Impurity 11 (CAS CATO-C4X-208411)
- Ethyl 5-amino-1-(4-(trifluoromethoxy)phenyl)-1h-pyrazole-4-carboxylate (CAS 400073-87-2)
- Lusutrombopag Impurity 18 (CAS 1110767-94-6)
- Luliconazole impurity 18 (CAS CATO-C4X-285318)
- Methotrexate Impurity N6 (CAS 4261-17-0)
- Relugolix Impurity 156 (CAS 737790-54-4)
- Glycerol Impurity 40 (CAS 64528-53-6)
- N-Benzyl-N-methylformamide (CAS 17105-71-4)
- Spiro[4.4]nonan-2-amine (CAS 1894946-27-0)
- 2,5-Dihydroxy-3-methylbenzaldehyde (CAS 108372-60-7)
- N-Desisopropyl Pentisomide (CAS 106132-93-8)
- 1-(2-Chlorobenzyl)piperidin-4-amine hydrochloride (CAS 1158219-47-6)
- Semaglutide impurity 270 (CAS CATO-C4X-2226270)
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