Description

Flupentixol Impurity D is a designated reference standard used in the analytical profiling of the antipsychotic drug Flupentixol. This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a key marker for identifying and quantifying process-related impurities. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Flupentixol and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Flupentixol Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Critical component in developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Flupentixol API meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various storage conditions.
• Research & Development: Used in synthetic chemistry research to understand and optimize the Flupentixol manufacturing process to minimize impurity formation.

Basic Information

Item	Detail
Product Name	Flupentixol Impurity D
CAS No.	791521-96-5
Molecular Formula	C₂₃H₂₅F₃N₂OS
Molecular Weight	434.52 g/mol
Synonyms	2-[4-[3-(2-Trifluoromethyl-9H-thioxanthen-9-ylidene)propyl]piperazin-1-yl]ethanol; cis-Flupentixol Impurity D; Flupentixol Related Compound D; (Z)-Flupentixol Impurity D; 9-[3-[4-(2-Hydroxyethyl)piperazin-1-yl]propylidene]-2-(trifluoromethyl)thioxanthene; Flupentixol EP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Flupentixol Impurity D is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment to ensure traceability and compliance with current industry and regulatory 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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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