Description

Nebivolol Impurity 15 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Nebivolol. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Nebivolol API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation of degradation products in Nebivolol under various stress conditions (e.g., heat, light, humidity) during stability testing.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Research and Development (R&D): Facilitates impurity profiling during the synthetic route development and process optimization of Nebivolol.

Basic Information

Product Name	Nebivolol Impurity 15
CAS No.	119365-29-6
Molecular Formula	C22H25F2NO4
Molecular Weight	405.44 g/mol
Synonyms	1-(6-Fluorochroman-2-yl)-2-{[2-(6-fluorochroman-2-yl)-2-hydroxyethyl]amino}ethanol; (RS)-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; Nebivolol Related Compound; Nebivolol Process Impurity; Nebivolol Degradant
EINECS	Contact for details

Quality Control

Our Nebivolol Impurity 15 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with ICH guidelines for impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and mass spectrometry analyses.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept sealed when not in use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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