Description

Clozapine-D8 CAS NO 1185053-50-2 is a deuterated analog of the antipsychotic drug clozapine, where eight hydrogen atoms are replaced with deuterium. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in mass spectrometry. It is primarily required by pharmaceutical research laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug metabolism and pharmacokinetics (DMPK) studies, therapeutic drug monitoring, and forensic toxicology.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of clozapine and its metabolites in biological matrices such as plasma, serum, and urine.
• Pharmacokinetic and Bioequivalence Studies: Enables accurate measurement of drug concentration over time to assess absorption, distribution, metabolism, and excretion.
• Therapeutic Drug Monitoring (TDM): Supports clinical laboratories in monitoring clozapine levels in patient samples to optimize dosage and minimize side effects.
• Metabolite Identification and Profiling: Aids in the structural elucidation and quantification of clozapine metabolites in research settings.
• Forensic and Clinical Toxicology: Used in confirmatory testing for the presence of clozapine in forensic investigations or overdose cases.
• Method Development and Validation: Serves as a key component in developing and validating robust, regulatory-compliant analytical methods (e.g., following FDA/EMA guidelines).

Basic Information

Item	Detail
Product Name	Clozapine-D8
CAS No.	1185053-50-2
Molecular Formula	C18H11D8ClN4
Molecular Weight	334.86 g/mol (for unlabeled base; exact mass varies with isotopic purity)
Synonyms	8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine-D8; Clozapine-d8; Deuterated Clozapine; Clozaril-D8; Leponex-D8; Clopin-D8; 5H-Dibenzo[b,e][1,4]diazepine, 8-chloro-11-(4-methyl-1-piperazinyl)-, D8-labeled; Clozapine (phenyl-D5, piperazine-D3)
EINECS	Contact for details

Quality Control

Every batch of Clozapine-D8 is produced and tested under strict quality management systems. We guarantee high chemical and isotopic purity, verified by advanced analytical techniques including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, isotopic enrichment, and solvent content. Our quality commitment supports compliance with the rigorous standards required for pharmaceutical research and regulatory submissions.

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 product is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0% (Chemical Purity)
Isotopic Purity	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
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.