Description

Rel-Desfluoro Nebivolol Impurity is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Nebivolol, a β-blocker medication. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of a specific process-related impurity. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly those focused on method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Nebivolol and its related substances.
• Analytical Method Development & Validation: Crucial for developing and validating precise HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Nebivolol Active Pharmaceutical Ingredient (API) and finished dosage forms to ensure compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions and over shelf-life.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Nebivolol to minimize the formation of this impurity.

Basic Information

Product Name	Rel-Desfluoro Nebivolol Impurity
CAS No.	1416402-13-5
Molecular Formula	C21H25F2NO4
Molecular Weight	393.43 g/mol
Synonyms	1-(6-Fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)-2-[[2-(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)-2-hydroxyethyl]amino]ethanol (Desfluoro analog); Nebivolol Desfluoro Impurity; Nebivolol Related Compound; (2R*,2'S*)-1,1'-[(2R*,2'S*)-2,2'-iminobis[1-(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)ethanol]]; UNII-7VQ5N73W4K
EINECS	Contact for details

Quality Control

Every batch of Rel-Desfluoro Nebivolol Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. 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 controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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