Description

Flupentixol Impurity 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 active pharmaceutical ingredient (API) Flupentixol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Flupentixol API and its formulations.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods like HPLC and UPLC.
• Quality Control (QC) & Quality Assurance (QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products in Flupentixol under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity identity and control strategies.
• Research & Development: Used in chemical and pharmacological R&D to study the metabolism, synthesis pathways, and properties of Flupentixol-related compounds.

Basic Information

Product Name	Flupentixol Impurity
CAS No.	28973-34-4
Molecular Formula	C₂₃H₂₅F₃N₂OS
Molecular Weight	434.52 g/mol
Synonyms	Flupentixol Related Compound; Flupentixol EP Impurity; Flupentixol USP Impurity; 2-[4-[3-(2-Trifluoromethyl-9H-thioxanthen-9-ylidene)propyl]piperazin-1-yl]ethanol; cis(Z)-Flupentixol; Z-Flupentixol; Flupentixol Isomer; Fluanxol Impurity
EINECS	Contact for details

Quality Control

Our Flupentixol Impurity is manufactured under strict quality control protocols to ensure the highest standards of purity and consistency. Each batch is rigorously tested using validated analytical methods, including HPLC and spectroscopic techniques, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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 single unknown 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.