Nilotinib Impurity 17 CAS 916975-92-3
| CAS No. | 916975-92-3 |
| Molecular Formula | C11H8F3N3O2 |
| Molecular Weight | 271.20 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 Nilotinib Impurity 17.
Nilotinib Impurity 17 (CAS 916975-92-3) is a certified pharmaceutical impurity reference standard with the molecular formula C11H8F3N3O2 and a molecular weight of 271.20 g/mol.
Structurally, Nilotinib Impurity 17 (C11H8F3N3O2) 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 271.20 g/mol, it falls into the medium-molecular-weight range. 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.
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 | C11H8F3N3O2 |
| Molecular Weight | 271.20 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.) | 1987 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Nilotinib Standards
- Nilotinib Impurity 16 (CAS 641571-13-3)
- Nilotinib Impurity 15 (CAS 917391-28-7)
- 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
- Sulfadoxine Impurity 8 (CAS 2247-57-6)
- 1-[(2R,3R,4R,5R)-5-(azidomethyl)-3-fluoro-4-hydroxy-tetrahydrofuran-2-yl]pyrimidine-2,4-dione (CAS 1012080-88-4)
- N1-(4-bromobenzyl)-N3,N3-dimethylpropane-1,3-diamine (CAS 893583-21-6)
- 2-fluoro-4-[3-(trifluoromethoxy)phenyl]aniline (CAS 1035689-62-3)
- Ivabradine Impurity 32 (CAS CATO-C4X-111932)
- Agomelatine Impurity 48 (CAS CATO-C4X-110848)
- Triamcinolone EP Impurity B (CAS 3859-65-2)
- 4,4'-(Furan-2,5-diyl)bis(N-cyclopentylbenzimidamide) (CAS 192525-51-2)
- 2-(2-Chloro-5-cyano-6-(difluoromethyl)pyridin-3-yl)acetic acid (CAS 1805383-70-3)
- 1187168-99-5 2-Methyl-4-(4-propoxybenzoyl)pyridine MFCD13153310 (CAS 1187168-99-5)
- tert-Butyl (2S,5S)-5-allylpyrrolidine-2-carboxylate (CAS 549521-70-2)
- Clindamycin Impurity 5 (CAS CATO-C4X-13415)
- 2-Ethyl-1-Butanol (CAS 97-95-0)
- Semaglutide impurity 57 (CAS 2773558-06-6)
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