Description

Clozapine Ep Impurity D CAS NO 65514-71-8 is a specified impurity of the antipsychotic drug Clozapine, crucial for ensuring the safety and efficacy of the final pharmaceutical product. This compound is essential for analytical method development, validation, and quality control testing in pharmaceutical research and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in the development and production of Clozapine and related compounds.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Clozapine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Critical for developing and validating high-performance liquid chromatography (HPLC), UPLC, or other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine batch testing to ensure Clozapine products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH stability guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product quality.
• Research & Development: Serves as a key intermediate or marker in studies investigating the synthesis, metabolism, or degradation pathways of Clozapine.

Basic Information

Product Name	Clozapine Ep Impurity D
CAS No.	65514-71-8
Molecular Formula	C18H19ClN4
Molecular Weight	326.82 g/mol
Synonyms	8-Chloro-11-(4-methylpiperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine; Clozapine Impurity D; Clozapine Related Compound D; Clozapine EP Impurity D; 5H-Dibenzo[b,e][1,4]diazepine, 8-chloro-11-(4-methyl-1-piperazinyl)-; Clozapine Impurity 4 (EP); Clozapine Specified Impurity D
EINECS	Contact for details

Quality Control

Our Clozapine Ep Impurity D is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. The product is suitable for use as a pharmaceutical reference standard and is characterized in compliance with current ICH guidelines and relevant pharmacopeial standards.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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