Nebivolol Hydrochloride EP Impurity B CAS 119365-23-0
| CAS No. | 119365-23-0 |
| 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 Hydrochloride EP Impurity B.
CATO supplies Nebivolol Hydrochloride EP Impurity B (CAS 119365-23-0), a pharmacopoeial impurity reference standard (molecular formula C22H25F2NO4, MW 405.44 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Nebivolol Hydrochloride 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. 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.
As a certified reference material (CRM), Nebivolol Hydrochloride EP Impurity B meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
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 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 EP Impurity B (CAS CATO-C4X-196847)
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)
- Eltrombopag Impurity 129 (CAS CATO-C4X-1198129)
- Orforglipron Impurity 53 (CAS CATO-C4X-323453)
- Flomoxef Impurity 9 Sodium Sal (CAS 2095697-77-9 (free acid))
- n-(2-Methoxyphenyl)piperidine-3-carboxamide (CAS 1016503-75-5)
- 2-Ethoxy-5-(3-nitrobenzamido)benzenesulfonyl chloride (CAS 680618-00-2)
- 3-Fluoro-N-(methylsulfonyl)benzimidamide (CAS 1820590-21-3)
- Formaldehyde In Water (CAS CATO-CCRM106074)
- (S)-2-(Pyrrolidin-2-yl)acetonitrile (CAS 1186242-37-4)
- 5,5-Difluorohexanenitrile (CAS 2368-89-0)
- Hexapeptide-9 (CAS 1228371-11-6)
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