Description

Clozapine (D4) is a deuterium-labeled analog of the atypical antipsychotic clozapine, specifically designed for use as an internal standard in analytical chemistry. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and metabolic studies. It is a critical tool for researchers and quality control laboratories in the pharmaceutical, forensic, and clinical diagnostics sectors who require precise measurement of clozapine levels.

Application

• Internal Standard for LC-MS/MS: Primary use as a stable, isotopically labeled internal standard for the precise quantification of clozapine in biological matrices (e.g., plasma, serum) using liquid chromatography-tandem mass spectrometry.
• Pharmacokinetic Research: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and preclinical studies.
• Therapeutic Drug Monitoring (TDM): Supports the development and validation of robust analytical methods for monitoring clozapine concentrations in patient samples to optimize dosing and ensure therapeutic efficacy while minimizing side effects.
• Metabolite Identification: Aids in the identification and quantification of clozapine metabolites in complex biological systems.
• Forensic and Toxicology Analysis: Used in forensic laboratories for the accurate determination of clozapine in post-mortem or legal casework samples.
• Method Development and Validation: Serves as a critical reference material for developing, calibrating, and validating new analytical protocols in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Pharmaceutical Manufacturing: Employed in QC labs to verify the purity and concentration of clozapine in active pharmaceutical ingredients (APIs) and finished drug products.

Basic Information

Product Name	Clozapine (D4)
CAS No.	204395-52-8
Molecular Formula	C18H15D4ClN4
Molecular Weight	330.82 g/mol (for D4 isotopologue)
Synonyms	Clozapine-d4; 8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine-d4; Deuterated Clozapine; Clozapine (tetradeuterated); Clozaril-d4; Leponex-d4; 5H-Dibenzo[b,e][1,4]diazepine, 8-chloro-11-(4-methyl-1-piperazinyl)-, tetradeuterated
EINECS	Contact for details

Quality Control

Our Clozapine (D4) is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for analytical applications. Each batch is subjected to rigorous testing, including HPLC for chemical purity and MS for isotopic purity and enrichment. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your method validation and regulatory compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (MS)	≥98 atom % D
Chemical Purity	≥95% (by HPLC)
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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