Nebivolol Impurity 12（RS,SR） CAS 119365-30-9
| CAS No. | 119365-30-9 |
| Molecular Formula | C22H25F2NO4 |
| Molecular Weight | 405.44 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 Nebivolol Impurity 12（RS,SR）.
As a process- or degradation-related impurity, Nebivolol Impurity 12（RS,SR） (CAS 119365-30-9, C22H25F2NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Nebivolol Impurity 12（RS,SR） (C22H25F2NO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
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 |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Nebivolol Standards
- 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)
- Nebivolol EP Impurity B (CAS CATO-C4X-196847)
Recommended Standards
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- Enalapril Impurity 31 (CAS CATO-C4X-133431)
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