Nilotinib Hydrochloride Monohydrate EP Impurity H CAS 641571-15-5
| CAS No. | 641571-15-5 |
| Molecular Formula | C28H22F3N7O |
| Molecular Weight | 529.52 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Nilotinib Hydrochloride Monohydrate EP Impurity H (CAS 641571-15-5, C28H22F3N7O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C28H22F3N7O, Nilotinib Hydrochloride Monohydrate EP Impurity H contains a steroid core, 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 529.52 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
Physical & Chemical Properties
| Molecular Formula | C28H22F3N7O |
| Molecular Weight | 529.52 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 20.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1985 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 7 |
Related Nilotinib Standards
- Nilotinib (CAS 641571-10-0)
- Nilotinib Impurity 9 (CAS 641571-05-3)
- Nilotinib Impurity 42 (CAS CATO-C4X-125642)
- Nilotinib-d3 (CAS 1215678-43-5)
- Nilotinib-d6 (CAS 1268356-17-7)
- Nilotinib Impurity 43 (CAS CATO-C4X-125643)
- Nilotinib Hydrochloride Monohydrate EP Impurity F (CAS 2119583-24-1)
- Nilotinib EP Impurity E (CAS 2119583-26-3)
Recommended Standards
- Cefoperazone EP Impurity A (CAS 73240-08-1)
- Regorafenib Impurity 9 (CAS CATO-C4X-10479)
- N-((5-((2-((4-Fluorophenyl)amino)-2-oxoethyl)thio)-4-(3-(trifluoromethyl)phenyl)-4H-1,2,4-triazol-3-yl)methyl)benzamide (CAS 393839-83-3)
- Cefoperazone Impurity N3 (CAS 73240-09-2)
- Terbinafine Impurity 48 (CAS CATO-C4X-133848)
- Upadacitinib Impurity 59 (CAS 2411540-28-6)
- Tolvaptan Impurity 62 (CAS 2657689-30-8)
- 1-(2-Methylpyridin-3-yl)ethanol (CAS 90086-87-6)
- Methyl 4-(2-Chlorophenyl)-4-cyanobutyrate (CAS 2006276-81-7)
- 4-(7-Methoxy-1-benzofuran-2-yl)-1,3-thiazol-2-amine (CAS 100136-48-9)
- 2-({4-[(e)-(3-methyl-4-{[(4-methylphenyl)sulfonyl]oxy}phenyl)diazenyl]phenyl}amino)-5-nitrobenzenesulfonic acid 99569-11-6 AR-1C5916 (CAS 99569-11-6)
- 700-92-5 Thiazolidine, 2-(4-pyridyl)- BRN 3941125 2-(4-Pyridyl) thiazolidine (Pyridyl-4)-2 thiazolidine [French] (Pyridyl-4)-2 thiazolidine (CAS 700-92-5)
- Clothianidin-13C4-15N (CAS CATO-CCPD102484)
- Tau Peptide (294-305) (human) trifluoroacetate salt (CAS 1428135-29-8)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com