Description

Nebivolol Impurity 28 Hcl (Ss,Rs) CAS NO 920299-27-0 is a specific stereoisomeric impurity of the β-blocker Nebivolol. This compound is of critical importance for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is essential for quality control laboratories and R&D teams in the pharmaceutical industry who require high-purity impurities to ensure the safety, efficacy, and regulatory compliance of Nebivolol-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Nebivolol Active Pharmaceutical Ingredients (APIs).
• Analytical Method Development: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Assurance & Control (QA/QC): Used in routine batch testing to ensure Nebivolol API and finished drug products meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific stereoisomeric impurity.

Basic Information

Product Name	Nebivolol Impurity 28 Hcl (Ss,Rs)
CAS No.	920299-27-0
Molecular Formula	C22H26F2NO4 • HCl
Molecular Weight	441.90 g/mol (Free base: 406.45 g/mol)
Synonyms	Nebivolol Related Compound 28; (SS,RS)-Nebivolol Impurity 28 Hydrochloride; 1-(6-Fluorochroman-2-yl)-2-[[2-(6-fluorochroman-2-yl)-2-hydroxy-ethyl]amino]ethanol hydrochloride (SS,RS isomer); UNII-9J4V8C8N3R; Nebivolol EP Impurity 28; Nebivolol USP Impurity 28; (αRS,2RS)-rel-1,1'-[2,2'-Iminobis(2,1-ethanediyloxy)]bis[6-fluorochroman] Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Nebivolol Impurity 28 Hcl (Ss,Rs) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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