Description

Chlorprothixene Ep Impurity F is a high-purity chemical reference standard, specifically identified as an impurity of the antipsychotic drug Chlorprothixene. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during drug substance and product manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Primary use as a certified reference standard (CRS) for analytical method development and validation.
• Critical component in impurity profiling and stability studies of Chlorprothixene Active Pharmaceutical Ingredients (APIs).
• Used for system suitability testing and calibration in High-Performance Liquid Chromatography (HPLC) and related chromatographic techniques.
• Essential for conducting pharmacopoeial compliance testing (e.g., EP, USP) to meet stringent regulatory requirements.
• Supports research into the degradation pathways and metabolism of Chlorprothixene.
• Employed in quality control laboratories to establish and verify specification limits for this impurity.

Basic Information

Item	Details
Product Name	Chlorprothixene Ep Impurity F
CAS No.	4546-35-4
Molecular Formula	C₁₈H₁₈ClNS
Molecular Weight	315.86 g/mol
Synonyms	(Z)-2-Chloro-9-[3-(dimethylamino)propylidene]thioxanthene; (Z)-Chlorprothixene; cis-Chlorprothixene; Chlorprothixene Impurity F; Chlorprothixene Related Compound F; Thioxanthene, 2-chloro-9-[3-(dimethylamino)propylidene]-, (Z)-; NSC 115973
EINECS	Contact for details

Quality Control

Every batch of Chlorprothixene Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopoeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.