Description

D-Nebivolol, Hydrochloride (1:1) is a high-purity, single-enantiomer active pharmaceutical ingredient (API) and key intermediate. This compound is the pharmacologically active dextrorotatory isomer of the β-blocker nebivolol, prized for its high selectivity and favorable side-effect profile. It is essential for pharmaceutical R&D, process development, and the commercial manufacturing of advanced cardiovascular medications targeting hypertension and heart failure.

Application

• Pharmaceutical API Synthesis: Primary use as the active ingredient in the manufacture of enantiomerically pure nebivolol-based drugs.
• Cardiovascular Drug Formulation: Critical intermediate for producing finished dosage forms (tablets, capsules) for antihypertensive therapies.
• Research & Development: Used in pharmacological studies, metabolic pathway analysis, and clinical trial material (CTM) preparation.
• Process Chemistry & Scale-Up: Serves as a reference standard and starting material for optimizing synthetic routes and scaling production.
• Analytical Standard: Employed as a certified reference material (CRM) for HPLC, LC-MS, and chiral purity assays in quality control laboratories.

Basic Information

Product Name	D-Nebivolol, Hydrochloride (1:1)
CAS No.	213132-06-0
Molecular Formula	C22H25F2NO4 • HCl
Molecular Weight	441.90 g/mol (Free base: 405.44)
Synonyms	(+)-Nebivolol Hydrochloride; D-Nebivolol HCl; (2R,3S)-Nebivolol Hydrochloride; (αR,βS)-6-Fluoro-3,4-dihydro-2H-1-benzopyran-2,7-diol Hydrochloride; SRRR-Nebivolol Hydrochloride; Bystolic (D-isomer) API; 1-(6-Fluorochroman-2-yl)-2-[[2-(6-fluorochroman-2-yl)-2-hydroxy-ethyl]amino]ethanol hydrochloride
EINECS	Contact for details

Quality Control

Our D-Nebivolol, Hydrochloride (1:1) is manufactured under strict quality management systems. Each batch is tested to meet exacting standards for pharmaceutical intermediates, with a focus on chiral purity, chemical identity, and impurity profiles. A comprehensive Certificate of Analysis (COA) detailing results for assay, enantiomeric excess, related substances, residual solvents, and microbiological limits is provided with every shipment to ensure traceability and regulatory compliance.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere packing.

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)	≥98.5% (on anhydrous basis)
Enantiomeric Purity (Chiral HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤1.5%; Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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