Description

Flunarizine Ep Impurity C is a specified impurity used in the analytical profiling and quality control of the pharmaceutical active ingredient Flunarizine. This compound is critical for ensuring the purity, safety, and efficacy of Flunarizine-based drug products by serving as a reference standard in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Flunarizine Ep Impurity C in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Flunarizine API and formulations.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Flunarizine batches comply with International Conference on Harmonisation (ICH) guidelines and pharmacopeial monographs (e.g., EP, USP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate control over the impurity profile.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Flunarizine Ep Impurity C
CAS No.	90830-31-2
Molecular Formula	C26H26F2N2
Molecular Weight	404.50 g/mol
Synonyms	1-[Bis(4-fluorophenyl)methyl]-4-[(2E)-3-phenylprop-2-en-1-yl]piperazine; (E)-1-(Bis(4-fluorophenyl)methyl)-4-(3-phenylallyl)piperazine; Flunarizine Impurity C; Flunarizine Related Compound C; Sibelium Impurity C; (E)-Cinnamyl Flunarizine; Trans-Cinnamyl Flunarizine
EINECS	Contact for details

Quality Control

Our Flunarizine Ep Impurity C is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, and identification tests performed using validated methods (e.g., HPLC, NMR, MS). We adhere to ICH Q3A/B guidelines and can support compliance with cGMP standards for pharmaceutical impurity standards.

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); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture.

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 impurity ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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