Description

Nebivolol Impurity 2 Hcl (Sr,Rs) CAS NO 920275-19-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Nebivolol. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Nebivolol API.
• Critical component in analytical method development and validation (HPLC, LC-MS) for pharmaceutical quality control.
• Used in stability studies to monitor impurity profiles and degradation pathways of Nebivolol formulations.
• Essential for regulatory compliance and filing (e.g., ICH guidelines, FDA, EMA submissions) requiring impurity characterization.
• Supports pharmaceutical research into the synthesis, metabolism, and pharmacokinetics of Nebivolol and related compounds.
• Acts as a calibration standard in laboratory settings to ensure the accuracy and precision of analytical instruments.

Basic Information

Product Name	Nebivolol Impurity 2 Hcl (Sr,Rs)
CAS No.	920275-19-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nebivolol Related Compound 2; (SR,RS)-Nebivolol Impurity 2 Hydrochloride; 1-(6-Fluorochroman-2-yl)-2-{[2-(6-fluorochroman-2-yl)-2-hydroxyethyl]amino}ethanol hydrochloride; Nebivolol EP Impurity B HCl; Nebivolol USP Impurity 2; Bystolic Impurity 2 HCl; (αR*,α'R*,2R*,2'S*)-rel-α,α'-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Nebivolol Impurity 2 Hcl (Sr,Rs) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial guidelines (e.g., USP, EP). Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

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 desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
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.