Description

Flupentixol Impurity 1 is a designated impurity standard of the antipsychotic pharmaceutical compound Flupentixol. This high-purity reference material is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily required by research institutions, analytical laboratories, and pharmaceutical companies engaged in the development, production, and regulatory compliance of Flupentixol-based drug products.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Flupentixol active pharmaceutical ingredient (API) and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, GC) to meet ICH Q2(R1) and pharmacopoeial guidelines.
• Critical component in stability studies and forced degradation studies to understand the degradation pathways of Flupentixol.
• Used for quality control and batch release testing to ensure drug substance and product purity and safety.
• Serves as a key material in regulatory submissions (e.g., for FDA, EMA) to establish impurity profiles and specifications.
• Supports research and development of new synthetic routes and purification processes for Flupentixol.

Basic Information

Product Name	Flupentixol Impurity 1
CAS No.	850808-70-7
Molecular Formula	C₂₃H₂₅F₃N₂OS
Molecular Weight	434.52 g/mol
Synonyms	Flupentixol Related Compound 1; Flupentixol EP Impurity B; Flupentixol USP Impurity; 2-Trifluoromethyl-9-[3-[4-(2-hydroxyethyl)piperazin-1-yl]propylidene]thioxanthene; (Z)-Flupentixol Impurity; Cis(Z)-Flupentixol Impurity; Thioxanthene derivative impurity of Flupentixol
EINECS	Contact for details

Quality Control

Every batch of Flupentixol Impurity 1 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 pharmacopoeial standards (e.g., USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere when appropriate 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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