Description

Flupentixol Ep Impurity A -G is a high-purity reference standard critical for the analytical profiling and quality control of the antipsychotic drug Flupentixol. This compound is essential for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is primarily used in method development, validation, and routine batch testing within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Flupentixol active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC, GC) for impurity profiling.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH, USP, and EP guidelines.
• Stability Studies: A key analyte in forced degradation and long-term stability studies of Flupentixol to understand degradation pathways.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of related substances in biological systems.

Basic Information

Product Name	Flupentixol Ep Impurity A -G
CAS No.	23904-98-5
Molecular Formula	C₂₃H₂₅F₃N₂OS
Molecular Weight	434.52 g/mol
Synonyms	Flupentixol EP Impurity A; Flupentixol Related Compound A; (Z)-Flupentixol; cis-Flupentixol; 2-[4-[3-(2-Trifluoromethyl-9H-thioxanthen-9-ylidene)propyl]piperazin-1-yl]ethanol; Flupentixol Impurity A; Flupentixol Isomer; α-Flupentixol
EINECS	Contact for details

Quality Control

Every batch of Flupentixol Ep Impurity A -G is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and stability conform to high-grade reference material standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.