Description

(R,S,S,S)-Nebivolol Hydrochloride CAS NO 920299-33-8 is a high-purity, stereochemically defined active pharmaceutical ingredient (API) and a key intermediate in advanced pharmaceutical synthesis. This compound is critical for research and development in cardiovascular therapeutics, offering a pathway to novel and generic drug formulations. It is primarily required by pharmaceutical manufacturers, R&D laboratories, and fine chemical suppliers engaged in the production of β-blocker medications and related chiral molecules.

Application

• Pharmaceutical API Synthesis: Primary use as an active pharmaceutical ingredient or critical intermediate in the manufacture of nebivolol-based cardiovascular drugs.
• Chiral Research & Development: Serves as a valuable reference standard and building block in stereoselective synthesis and pharmacological studies.
• Generic Drug Formulation: Essential for companies developing bioequivalent versions of branded β-blocker medications.
• Analytical Standard: Used as a high-purity certified reference material (CRM) for quality control and method validation in analytical laboratories.
• Preclinical & Clinical Studies: Employed in the preparation of dosage forms for pharmacological testing and clinical trial materials.
• Process Chemistry Optimization: Utilized for scaling up and optimizing synthetic routes in pilot plants and commercial production.

Basic Information

Product Name	(R,S,S,S)-Nebivolol Hydrochloride
CAS No.	920299-33-8
Molecular Formula	C22H25F2NO4 • HCl
Molecular Weight	441.90 g/mol (Free base: 405.44)
Synonyms	Nebivolol HCl (specified stereoisomer); (αR,α'R,2R,2'S)-α,α'-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] Hydrochloride; 1,1'-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] Hydrochloride (R,R,R,R-isomer); BRL-37344 (related to); SR-58611 (related to); D,L-Nebivolol Hydrochloride (racemic mixture); (R*,R*,R*,R*)-Nebivolol Hydrochloride
EINECS	Contact for details

Quality Control

Our (R,S,S,S)-Nebivolol Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity verification, to ensure it meets stringent specifications for pharmaceutical use. Certificates of Analysis (COA) are provided with each shipment, detailing results for identity, assay, impurities, and residual solvents. We support compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopeial standards (USP/EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Chiral Purity (Chiral HPLC)	≥ 99.0% (R,S,S,S isomer)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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