Description

Chlorpromazine Ep Impurity B is a designated pharmaceutical reference standard, specifically a known impurity of the antipsychotic drug Chlorpromazine. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and regulatory compliance. It is primarily used by research and development laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the production and analysis of Chlorpromazine and related phenothiazine derivatives.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of this specific impurity in Chlorpromazine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods to ensure specificity, accuracy, and precision.
• Stability Studies and Forced Degradation Testing: Employed as a marker to understand degradation pathways and establish shelf-life specifications for Chlorpromazine formulations.
• Regulatory Compliance and Submissions: Essential for meeting the requirements of pharmacopoeial standards (USP, EP, BP) and regulatory bodies (FDA, EMA) for drug approval and market authorization, which mandate the control and reporting of known impurities.
• Quality Control and Batch Release Testing: Used in routine QC testing to ensure that Chlorpromazine API and drug products meet stringent purity specifications and are free from unacceptable levels of this impurity.
• Academic and Clinical Research: Supports investigative studies on the metabolism, pharmacokinetics, and potential toxicity of Chlorpromazine and its related compounds.

Basic Information

Product Name	Chlorpromazine Ep Impurity B
CAS No.	19077-20-4
Molecular Formula	C17H19ClN2S
Molecular Weight	318.86 g/mol
Synonyms	3-(2-Chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1-amine; Chlorpromazine Impurity B; Chlorpromazine Related Compound B; Chlorpromazine EP Impurity B; 10-[3-(Dimethylamino)propyl]-2-chlorophenothiazine; N,N-Dimethyl-3-(2-chlorophenothiazin-10-yl)propan-1-amine; Chlorpromazine Sulfoxide (Note: This is a common misidentification; verify structure for specific isomer).
EINECS	Contact for details

Quality Control

Our Chlorpromazine Ep Impurity B is manufactured and handled under strict quality management systems. Each batch is subjected to rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

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)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	98.0% - 102.0%

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