Description

Flunarizine Ep Impurity B is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the calcium channel blocker Flunarizine by accurately identifying and quantifying this specific process-related impurity. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs to meet stringent pharmacopeial standards for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Flunarizine Ep Impurity B in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) assays.
• Quality Control and Batch Release: Used in routine QC testing to ensure Flunarizine API and finished drug products comply with International Council for Harmonisation (ICH) guidelines and pharmacopeial monographs (e.g., EP, USP) for impurity limits.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and impurity profile of Flunarizine.
• Research and Development: Supports process chemistry research aimed at understanding impurity formation pathways and optimizing synthesis to minimize its generation.

Basic Information

Product Name	Flunarizine Ep Impurity B
CAS No.	39245-25-5
Molecular Formula	C26H26F2N2
Molecular Weight	404.50 g/mol
Synonyms	1-[Bis(4-fluorophenyl)methyl]-4-[(E)-3-phenyl-2-propen-1-yl]piperazine; (E)-1-[Bis(4-fluorophenyl)methyl]-4-(3-phenylallyl)piperazine; Flunarizine Impurity B; Flunarizine Related Compound B; Flunarizine EP Impurity B; Cinnarizine Analog; (E)-Cinnarizine Derivative
EINECS	Contact for details

Quality Control

Every batch of Flunarizine Ep Impurity B 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 to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents, ensuring full traceability and compliance with current Good Manufacturing Practice (cGMP) principles.

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

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

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