Description

Flunarizine Impurity 5 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical substance Flunarizine. This high-purity compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams focused on developing and manufacturing high-quality active pharmaceutical ingredients (APIs).

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Critical component for impurity identification and quantification in Flunarizine API batches via HPLC, UPLC, or GC analysis.
• Essential for conducting stability studies and degradation pathway analysis of Flunarizine.
• Used in pharmaceutical research to study the synthesis and formation mechanisms of specific impurities.
• Serves as a system suitability standard in regulatory testing to comply with ICH Q3A/B guidelines.
• Supports quality control laboratories in establishing specification limits for impurities.

Basic Information

Product Name	Flunarizine Impurity 5
CAS No.	27064-96-6
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 Related Compound; Flunarizine EP Impurity; Flunarizine USP Impurity; (E)-Cinnamyl Flunarizine; Contact for details on additional aliases.
EINECS	Contact for details

Quality Control

Every batch of Flunarizine Impurity 5 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, NMR), and residual solvent analysis to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with relevant pharmacopeial guidelines (e.g., USP, EP).

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 (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage under inert atmosphere, please contact our technical team.

Specification

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

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