Nilotinib Hydrochloride Monohydrate EP Impurity C CAS 2458-12-0
| CAS No. | 2458-12-0 |
| Molecular Formula | C8H9NO2 |
| Molecular Weight | 151.16 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Nilotinib Hydrochloride Monohydrate EP Impurity C (CAS 2458-12-0, C8H9NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C8H9NO2, Nilotinib Hydrochloride Monohydrate EP Impurity C contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 151.16 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C8H9NO2 |
| Molecular Weight | 151.16 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Nitrogen Atoms | 1 |
Related Nilotinib Standards
- Nilotinib Impurity 17 (CAS 18595-17-0)
- Nilotinib EP Impurity B (CAS 18595-18-1)
- Nilotinib 2-Pyridinyl Impurity (CAS 66521-65-1)
- (Z)-Nilotinib Impurity 37 (CAS 75415-01-9)
- Nilotinib Impurity 25 (CAS 41574-91-8)
- Nilotinib Impurity 50 (CAS CATO-C4X-125650)
- Nilotinib Impurity 51 (CAS CATO-C4X-125651)
- Nilotinib Impurity 40 (CAS 859026-97-4)
Recommended Standards
- Paracetamol EP Impurity G (CAS 34523-34-7)
- Cefaclor EP Impurity A (CAS 875-74-1)
- Paracetamol EP Impurity A (CAS 614-80-2)
- Pregabalin Impurity 63 (CAS 7214-61-1)
- Ledipasvir Impurity 20 (CAS CATO-C4X-331320)
- Cefditoren Impurity 48 (CAS CATO-C4X-135848)
- Zanamivir EP Impurity E (CAS CATO-C4X-20505)
- 1-Cinnamyl-4-(phenylsulfonyl)piperazine (CAS 5264-21-1)
- 3-(6-Amino-1h-indazol-1-yl)propanamide (CAS 1155103-73-3)
- 3-(3-(3-(Difluoromethoxy)phenyl)-1,2,4-oxadiazol-5-yl)aniline (CAS 1779133-70-8)
- 3-Cyclopropoxy-N2,N2,N5-trimethylpyridine-2,5-diamine (CAS 1243348-83-5)
- 3-Amino-1-(5-chloro-2-methoxyphenyl)propan-1-ol (CAS 1226423-11-5)
- 4-amino-N-(butan-2-yl)-3-methylbenzamide (CAS 926233-21-8)
- Atrial Natriuretic Polypeptide (4-28), human (CAS 95896-08-5)
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