Description

Nebivolol Related Compound 1 Hcl (Mixture Of (Rr,Sr) And (Ss,Rs) Isomer) is a key analytical reference standard used in the pharmaceutical development and quality control of the β-blocker Nebivolol. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on cardiovascular drug manufacturing.

Application

• Pharmaceutical Impurity Profiling and Identification in Nebivolol API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for accurate quantification of related substances.
• Quality Control and Release Testing to ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies to monitor the formation of degradation products under various stress conditions.
• Regulatory Submission and Compliance, providing necessary data for drug master files (DMFs) and new drug applications (NDAs/ANDAs).
• Calibration Standard for ensuring the accuracy and precision of chromatographic systems in QC laboratories.

Basic Information

Product Name	Nebivolol Related Compound 1 Hcl (Mixture Of (Rr,Sr) And (Ss,Rs) Isomer)
CAS No.	1338823-20-3
Molecular Formula	C22H26F2NO4 • HCl
Molecular Weight	451.91 g/mol (Free base: 414.45 g/mol)
Synonyms	Nebivolol Impurity 1; Nebivolol Related Substance 1; (Rr,Sr)- and (Ss,Rs)-Nebivolol Hydrochloride Isomer Mixture; 1-(6-Fluorochroman-2-yl)-2-[[2-(6-fluorochroman-2-yl)-2-hydroxy-1-methylethyl]amino]ethanol hydrochloride (isomeric mixture); Nebivolol Diastereomer Mixture HCl; Nebivolol EP Impurity B HCl; Nebivolol USP Related Compound 1
EINECS	Contact for details

Quality Control

Our Nebivolol Related Compound 1 Hcl is manufactured under strict quality systems suitable for use as a reference standard. Every batch is characterized and tested using advanced analytical techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitable for regulatory filing and GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Assay (HPLC)	≥ 95.0% (on anhydrous basis)
Purity (HPLC, Area %)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
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.