Description

Chlorprothixene Ep Impurity D is a high-purity reference standard specifically used in the analytical profiling and quality control of the antipsychotic drug Chlorprothixene. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and stability studies within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Chlorprothixene impurities in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, and LC-MS/MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor and control the levels of specified impurities, ensuring final drug product meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of drug stability testing protocols.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research aimed at optimizing manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Chlorprothixene Ep Impurity D
CAS No.	1082649-26-0
Molecular Formula	C18H18ClNS
Molecular Weight	315.86 g/mol
Synonyms	(Z)-2-Chloro-9-[3-(dimethylamino)propylidene]thioxanthene; (Z)-Chlorprothixene Impurity D; Chlorprothixene Related Compound D; Chlorprothixene Isomer; cis-Chlorprothixene Impurity; Thioxanthene derivative; Chlorprothixene EP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Chlorprothixene Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and spectroscopic confirmation is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. Due to its hygroscopic nature, the container must be kept tightly sealed in a desiccated environment to prevent moisture absorption.

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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