Description

Clozapine n-Glucuronide is a major, pharmacologically inactive metabolite of the atypical antipsychotic drug clozapine. This reference standard is critical for pharmaceutical research and development, particularly in the fields of drug metabolism and pharmacokinetics (DMPK). It is primarily used by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies for bioanalytical method development, validation, and clinical study support.

Application

• Bioanalytical Reference Standard: Serves as a certified standard for the quantitative analysis of clozapine and its metabolites in biological matrices (plasma, serum, urine) using LC-MS/MS or HPLC.
• Pharmacokinetic Studies: Essential for understanding the metabolic fate, clearance pathways, and exposure levels of clozapine in preclinical and clinical studies.
• DMPK Research: Used in drug metabolism and pharmacokinetics research to investigate glucuronidation pathways and metabolic stability.
• Therapeutic Drug Monitoring (TDM): Supports the development and quality control of assays used to monitor clozapine levels in patients for efficacy and safety.
• Impurity Profiling: Acts as a known impurity or degradation product reference in the quality control of clozapine active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) requiring comprehensive metabolite identification and quantification.

Basic Information

Product Name	Clozapine n-Glucuronide
CAS No.	165602-86-8
Molecular Formula	C24H26ClN5O7
Molecular Weight	532.95 g/mol
Synonyms	Clozapine N-Glucuronide; Clozapine N(+)-Glucuronide; 8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine N-Glucuronide; Clozapine Glucuronide; N-Desmethylclozapine Glucuronide (related metabolite); Norclozapine N-Glucuronide; LOXAPINE metabolite (structurally related); Clozapine Major Inactive Metabolite
EINECS	Contact for details

Quality Control

Our Clozapine n-Glucuronide is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency suitable for analytical and research applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity confirmation, and impurity profiles. We adhere to relevant industry standards for reference materials.

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. This compound is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥95.0% (Area %)
Water Content (KF)	≤5.0%
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.