Description

9-Hydroxyl Clozapine is a significant metabolite of the atypical antipsychotic drug clozapine, offering critical value in pharmaceutical research and development. This compound is primarily utilized as a key reference standard and analytical tool for pharmacokinetic studies, metabolic profiling, and bioanalytical method validation. It is essential for researchers and quality control laboratories in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors who require high-purity materials to ensure accurate and reliable analytical data.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification of clozapine and its metabolites in biological matrices.
• Metabolite Identification & Profiling: Critical for in vitro and in vivo studies to understand the metabolic pathways and pharmacokinetics of clozapine.
• Bioanalytical Method Development: Serves as a critical standard for developing and validating HPLC, LC-MS, and GC-MS methods in clinical and preclinical research.
• Pharmacology Research: Employed in studies investigating the activity, toxicity, and receptor binding profiles of clozapine metabolites.
• Quality Control & Assurance: Used by API and finished dosage form manufacturers to monitor impurities and ensure product consistency and compliance.
• Forensic & Clinical Toxicology: Aids in the accurate detection and measurement of clozapine exposure in forensic and therapeutic drug monitoring (TDM) applications.

Basic Information

Product Name	9-Hydroxyl Clozapine
CAS No.	1239601-19-4
Molecular Formula	C18H19ClN4O
Molecular Weight	342.82 g/mol
Synonyms	9-Hydroxyclozapine; Clozapine 9-Hydroxy Metabolite; 9-OH-Clozapine; 8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepin-9-ol; Norclozapine 9-Hydroxy Metabolite; 9-Hydroxy Clozapine; 9-Hydroxy-8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine
EINECS	Contact for details

Quality Control

Our 9-Hydroxyl Clozapine is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment, supporting compliance with GLP and GMP guidelines for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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