Description

Flunarizine Ep Impurity D is a high-purity reference standard critical for the analytical profiling and quality control of the pharmaceutical compound Flunarizine. This impurity is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in the synthesis and analysis of Flunarizine.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments and validating methods in compliance with ICH guidelines.
• Method Development and Validation: Used in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Flunarizine active pharmaceutical ingredient (API).
• Quality Control & Assurance (QC/QA): Critical for the routine testing of Flunarizine batches to monitor and control impurity levels, ensuring they remain within specified safety thresholds.
• Regulatory Submissions: Provides essential data for impurity identification and characterization reports required by regulatory bodies like the FDA, EMA, and PMDA.
• Stability Studies: Employed to track the formation and growth of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Process Chemistry Research: Used by chemists to understand and optimize the Flunarizine synthesis pathway, helping to minimize the formation of this impurity.

Basic Information

Product Name	Flunarizine Ep Impurity D
CAS No.	693765-11-6
Molecular Formula	C26H26F2N2
Molecular Weight	404.50 g/mol
Synonyms	Flunarizine Related Compound D; Flunarizine Impurity D; (E)-1-[Bis(4-fluorophenyl)methyl]-4-[(2-fluorophenyl)methylidene]piperazine; 1,1-Bis(4-fluorophenyl)methyl-4-[(E)-2-fluorobenzylidene]piperazine; Flunarizine EP Impurity D; Flunarizine USP Impurity D; Flunarizine Process Impurity D
EINECS	Contact for details

Quality Control

Every batch of Flunarizine Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards (EP, USP) and ICH Q3A/B guidelines. 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 at controlled room temperature, 15-25°C, in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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