Nebivolol EP Impurity B CAS CATO-C4X-196847
| CAS No. | CATO-C4X-196847 |
| Molecular Formula | C22H25F2NO4 |
| Molecular Weight | 405.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Nebivolol EP Impurity B (CAS CATO-C4X-196847) is a certified pharmaceutical impurity reference standard with the molecular formula C22H25F2NO4 and a molecular weight of 405.44 g/mol.
The molecular framework of Nebivolol EP Impurity B (C22H25F2NO4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
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 | C22H25F2NO4 |
| Molecular Weight | 405.44 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Nebivolol Standards
- Nebivolol Impurity 12（RS,SR） (CAS 119365-30-9)
- Nebivolol Impurity 13（SR,SR） (CAS CATO-C4X-196813)
- Nebivolol Impurity 19 (CAS CATO-C4X-196819)
- Nebivolol Impurity 3（RR,SS） (CAS 1360598-84-0)
- L-Nebivolol (RS,SS) (CAS 118457-16-2)
- Nebivolol Impurity 31（RR,SR）or（RS,RR） (CAS 119365-26-3)
- Nebivolol Impurity 32（SS,RS）or（SR,SS） (CAS 119365-25-2)
- Nebivolol Hydrochloride EP Impurity B (CAS 119365-23-0)
Recommended Standards
- Nebivolol EP Impurity D (CAS CATO-C4X-196849)
- Nebivolol Impurity 5（RR,RR） (CAS 119365-29-6)
- Nebivolol Impurity 6（SS,SS） (CAS 119365-28-5)
- D-Nebivolol (SR,RR) (CAS 118457-15-1)
- Norethisterone EP Impurity F (CAS 96487-85-3)
- Ribociclib Impurity 8 (CAS 2460734-07-8)
- Sulfasalazine impurity 13 (CAS CATO-C4X-141913)
- 6870-79-7 Diosgenone (CAS 6870-79-7)
- Etoricoxib Impurity 83 (CAS CATO-C4X-108083)
- Ethyl 5-amino-1H-imidazole-4-carboxylate hydrochloride (CAS 118019-42-4)
- (R,R)-iPr-Dbfox (CAS 2634687-86-6)
- 5-Amino-6-bromopyridine-2-carboxylic acid (CAS 1402672-55-2)
- 1-(Aminomethyl)-6-thiaspiro[2.5]octane 6,6-dioxide (CAS 1478061-53-8)
- Palmitoyl Pentapeptide-4 (CAS 214047-00-4)
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