General Information

Nebivolol Impurities and Nebivolol

Daicel Pharma is a trusted provider of quality Nebivolol impurity standards, including(2S*,2’R*)-Nebivolol Impurity C, (2S*,​2’S*)​-​Nebivolol Impurity C, (R, S, R, R)-Nebivolol, (R, S, S, S)-Nebivolol, (R*)-2-(benzylamino)-1-((S*)-6-fluorochroman-2-yl)ethan-1-ol and many more. These impurities are critical in determining the active pharmaceutical ingredient Nebivolol’s quality, stability, and biological safety. Additionally, Daicel Pharma can synthesize Nebivolol impurities according to precise customer specifications while guaranteeing worldwide delivery.

Nebivolol [CAS No.: 99200-09-6] is a medication belonging to a class of drug beta-blockers. It primarily treats high blood pressure (hypertension) and certain heart conditions.

Nebivolol: Use and Commercial Availability   

Nebivolol is a beta-blocker and antihypertensive medication. It manages high blood pressure and blocks the action of certain chemicals in the body that can cause the narrowing of blood vessels, resulting in the relaxation and widening of blood vessels. Nebivolol manages coronary artery disease and chronic heart failure.

Nebivolol is available under the brand name Bystolic, which contains the active ingredient Nebivolol.

Nebivolol Structure and Mechanism of Action

The chemical name of Nebivolol is rel-(αR, α′R,2R,2′S)-α, α′-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol]. Its chemical formula is C₂₂H₂₅F₂NO₄, and its molecular weight is approximately 405.4 g/mol.

The mechanism of action of Nebivolol is unknown.

Nebivolol Impurities and Synthesis

Nebivolol impurities can arise during synthesis due to the storage or use of specific raw materials and intermediates in manufacturing. These impurities encompass related compounds, degradation products, and process impurities. Stringent quality control measures and analytical methods are crucial to ensure the purity and safety of Nebivolol for patient use.

Daicel Pharma provides a comprehensive Certificate of Analysis (CoA) for Nebivolol impurity standards, such as (2S*, 2’R*)-Nebivolol Impurity C, (2S*, ​2’S*)​-​Nebivolol Impurity C, (R, S, R, R)-Nebivolol, (R, S, S, S)-Nebivolol, (R*)-2-(benzylamino)-1-((S*)-6-fluorochroman-2-yl)ethan-1-ol and many more. The CoA includes detailed characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. Additionally, upon delivery, a complete 13C-DEPT is also provided. Daicel Pharma possesses the technology and expertise to synthesize any unknown Nebivolol impurity or degradation product. We offer labeled compounds to quantify the efficacy of generic Nebivolol. Daicel Pharma also supplies (R, S, S, S)-Nebivolol-D4, Nitroso Nebivolol D4, and (S, R, R, R)-Nebivolol-D4, deuterium-labeled compounds of Nebivolol, which are essential for BA/BE studies.