| CAS No. | 197706-51-7 |
| Molecular Formula | C11H11FO2 |
| Molecular Weight | 194.20 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Nebivolol Impurity 44 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Nebivolol Impurity 44 (CAS 197706-51-7), a pharmacopoeial impurity reference standard (molecular formula C11H11FO2, MW 194.20 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system, Nebivolol Impurity 44 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 194.20 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
| Molecular Formula | C11H11FO2 |
| Molecular Weight | 194.20 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2013 |
| Halogen Content | F-containing |