Nilotinib Impurity 16 CAS 641571-13-3
| CAS No. | 641571-13-3 |
| Molecular Formula | C12H9F3N2O2 |
| Molecular Weight | 270.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Nilotinib Impurity 16 (CAS 641571-13-3, C12H9F3N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C12H9F3N2O2, Nilotinib Impurity 16 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 270.21 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C12H9F3N2O2 |
| Molecular Weight | 270.21 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| 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.) | 1985 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Nilotinib Standards
- Nilotinib Impurity 15 (CAS 917391-28-7)
- Nilotinib Impurity 17 (CAS 916975-92-3)
- Nilotinib Impurity 14 (CAS 641571-12-2)
- Nilotinib Impurity 24 (CAS 641571-16-6)
- Nilotinib Hydrochloride Monohydrate EP Impurity A (CAS 641571-11-1)
- Nilotinib Bromo Impurity (CAS 54962-75-3)
- Nilotinib Impurity 19 (CAS CATO-C4X-125619)
- Nilotinib Impurity 18 (CAS 851137-91-2)
Recommended Standards
- Bicalutamide Impurity 14 (Bicalutamide Epoxide Impurity) (CAS 90357-51-0)
- Leflunomide (CAS 75706-12-6)
- 5-Ethynyl-1-(3-fluoro-4-hydroxy-5-hydroxymethyl-tetrahydro-furan-2-yl)-1H-pyrimidine-2,4-dione 5-ethynyl-1-[(2R,3S,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]pyrimidine-2,4-dione 95740-26-4 (CAS 95740-26-4)
- Leflunomide EP Impurity C (CAS 61643-23-0)
- Levocabastine EP Impurity H (CAS CATO-C4X-22898)
- Dasatinib Impurity 77 (CAS CATO-C4X-160777)
- Biotin Impurity 04 (CAS 26339-40-2)
- 5-Chloro-2-(chloromethyl)pyrimidine (CAS 944902-28-7)
- (R)-1-(3,4-dimethylphenyl)propan-1-amine (CAS 856758-69-5)
- (Z)-Ethyl 2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetate (CAS 64485-82-1)
- 4-Bromo-3,3-dimethylbutyrophenone (CAS 898764-38-0)
- Calcium L-aspartate (CAS 10389-09-0)
- 3-Nitrobenzimidohydrazide (CAS 60666-23-1)
- Liraglutide Impurity 6 TFA Salt (CAS CATO-C4X-19926)
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