Description

Flunarizine Impurity 2 is a specified impurity of the calcium channel blocker Flunarizine, identified by CAS NO 88172-16-1. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is an essential material for researchers and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Flunarizine Impurity 2 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of Flunarizine API.

Basic Information

Product Name	Flunarizine Impurity 2
CAS No.	88172-16-1
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 Related Compound; Flunarizine EP Impurity; Flunarizine USP Impurity; Sibelium Impurity
EINECS	Contact for details

Quality Control

Every batch of Flunarizine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.