Description

Flunarizine Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the pharmaceutical active ingredient Flunarizine. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Flunarizine drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or GC analytical methods for purity assays.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Acts as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Flunarizine formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and control strategies as per ICH guidelines.
• Research and Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Flunarizine.

Basic Information

Product Name	Flunarizine Impurity 6
CAS No.	768360-45-8
Molecular Formula	C26H26F2N2
Molecular Weight	404.50 g/mol
Synonyms	Flunarizine Related Compound 6; Flunarizine EP Impurity F; (E)-1-[Bis(4-fluorophenyl)methyl]-4-(3-phenyl-2-propen-1-yl)piperazine; 1-[(E)-Cinnamyl]-4-[(4,4'-difluorophenyl)methyl]piperazine; Flunarizine Impurity F; Flunarizine Process Impurity; Flunarizine Degradant
EINECS	Contact for details

Quality Control

Every batch of Flunarizine Impurity 6 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Our products are characterized using advanced techniques including HPLC, GC-MS, and NMR to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant 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) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
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
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.