Description

Flupentixol Impurity F is a designated impurity reference standard used in the analytical profiling and quality control of the antipsychotic pharmaceutical, Flupentixol. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of this specific impurity during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams focused on meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Flupentixol Impurity F in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) guidelines and pharmacopeial monographs (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control of impurities.
• Research and Development: Supports synthetic route optimization and impurity profiling during the development of Flupentixol and related compounds.

Basic Information

Product Name	Flupentixol Impurity F
CAS No.	756419-50-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Flupentixol Related Compound F; Flupentixol EP Impurity F; Flupentixol USP Impurity F; 2-[4-[3-(2-Trifluoromethyl-9H-thioxanthen-9-ylidene)propyl]piperazin-1-yl]ethanol (related to Flupentixol); Flupenthixol Impurity F; cis(Z)-Flupentixol Impurity F; Flupentixol Process Impurity; Flupentixol Degradant
EINECS	Contact for details

Quality Control

Our Flupentixol Impurity F is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and related substances. Our quality system supports compliance with current Good Manufacturing Practices (cGMP) and relevant ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under an inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
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.