Description

Clozapine-5-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 bioanalysis and drug metabolism studies. It is primarily used by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in pharmacokinetic profiling, method validation, and quality control of clozapine-based therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the quantitative and qualitative analysis of clozapine and its metabolites in biological matrices.
• Bioanalytical Method Development & Validation (FDA/EMA): Essential for developing and validating robust LC-MS/MS, HPLC, or UPLC methods for therapeutic drug monitoring (TDM) and clinical trials.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the glucuronidation pathway, metabolic stability, and excretion profiles of clozapine.
• Forensic and Clinical Toxicology: Acts as a key calibrant in assays designed to detect and quantify clozapine usage in patient samples or forensic investigations.
• Impurity Profiling and Characterization: Employed in the identification and control of potential process-related or degradation impurities in clozapine active pharmaceutical ingredient (API) manufacturing.
• Academic and Institutional Research: Supports fundamental research in neuropharmacology, metabolic enzyme kinetics, and pharmacogenomics related to antipsychotic drugs.

Basic Information

Product Name	Clozapine-5-n-Glucuronide
CAS No.	390651-03-3
Molecular Formula	C24H26ClN5O7
Molecular Weight	532.95 g/mol
Synonyms	Clozapine N(5)-Glucuronide; Clozapine 5-N-Glucuronide; 8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine-5-glucuronide; Clozapine N-Glucuronide; 5H-Dibenzo[b,e][1,4]diazepine-5-glucuronide, 8-chloro-11-(4-methyl-1-piperazinyl)-; Clozapine Glucuronide Metabolite; Norclozapine Glucuronide (related metabolite)
EINECS	Contact for details

Quality Control

Every batch of Clozapine-5-n-Glucuronide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and stability testing using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, chromatographic profile, and water content.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This compound is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake. For short-term use, store desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH guidelines
Specific Rotation	Contact for details

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