Description

(S,R,R,S)-Nebivolol is a specific stereoisomer of the β-blocker pharmaceutical compound nebivolol. This high-purity enantiomer is critical for advanced pharmaceutical research and development, particularly in studying structure-activity relationships and developing novel therapeutic formulations. It is primarily utilized by pharmaceutical R&D laboratories, analytical reference standard providers, and manufacturers of active pharmaceutical ingredients (APIs) for cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified analytical standard for method development, validation, and quality control testing of nebivolol-based drug products.
• Active Pharmaceutical Ingredient (API) Intermediate: Used in the synthesis and purification of the final nebivolol API, ensuring the correct stereochemical configuration for optimal therapeutic efficacy.
• Pharmacological Research: Essential for preclinical and clinical studies investigating the specific biological activity, metabolism, and pharmacokinetics of the (S,R,R,S)-nebivolol enantiomer.
• Impurity Profiling: Employed as a marker to identify, quantify, and control stereoisomeric impurities during the manufacturing process of racemic nebivolol or its single-enantiomer forms.
• Regulatory Submission Support: Provides characterized material for stability studies, impurity identification reports, and other documentation required for regulatory filings (e.g., with FDA, EMA).
• Method Development: A key component in developing and calibrating advanced chiral separation techniques, such as chiral HPLC or SFC, for stereochemical analysis.

Basic Information

Product Name	(S,R,R,S)-Nebivolol
CAS No.	119365-23-0
Molecular Formula	C22H25F2NO4
Molecular Weight	405.44 g/mol
Synonyms	1-(6-Fluorochroman-2-yl)-2-[[2-(6-fluorochroman-2-yl)-2-hydroxy-ethyl]amino]ethanol (S,R,R,S-isomer); Nebivolol Enantiomer; Nebivolol Stereoisomer; (2S,1'R,1''S)-1,1'-[(2RS)-2,2'-iminodiethanol]bis(6-fluorochroman); Bystolic Enantiomer; R 065-824 Enantiomer
EINECS	Contact for details

Quality Control

Our (S,R,R,S)-Nebivolol is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and stereochemical integrity, meeting the stringent requirements for pharmaceutical research materials. Certificates of Analysis (COA) detailing results for assay, chiral purity, related substances, and residual solvents are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Chiral Purity (Chiral HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.