Description

Mirtazapine n-Glucuronide (Mixture Of Diastereomers) Contains Unknown Inorganics >80% is a key metabolite reference standard of the antidepressant drug Mirtazapine. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily used by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in drug discovery and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the quantitative and qualitative analysis of Mirtazapine and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance rates, and bioavailability of Mirtazapine in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Essential for developing, calibrating, and validating sensitive analytical methods such as LC-MS/MS and HPLC for therapeutic drug monitoring (TDM) and bioequivalence studies.
• Impurity Profiling and Characterization: Aids in the identification and quantification of glucuronidated metabolite impurities in active pharmaceutical ingredient (API) batches to ensure drug safety and purity.
• Forensic and Clinical Toxicology: Employed as a calibrant or control in assays designed to detect and quantify Mirtazapine usage in forensic investigations or clinical overdose cases.
• Regulatory Submission Support: Provides essential data for regulatory filings (e.g., with FDA, EMA) requiring comprehensive metabolite identification and safety profiling.

Basic Information

Product Name	Mirtazapine n-Glucuronide (Mixture Of Diastereomers) Contains Unknown Inorganics >80%
CAS No.	1080533-15-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirtazapine N-Glucuronide; Mirtazapine Glucuronide; 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine Glucuronide; Mirtazapine Metabolite Glucuronide; 6-Azapirane Glucuronide; Remeron Glucuronide Metabolite; N-Glucuronidated Mirtazapine
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Every batch of Mirtazapine n-Glucuronide is analyzed to confirm identity, purity, and stability, making it suitable for demanding research and analytical applications. Certificates of Analysis (COA) containing detailed chromatographic data and specifications are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	>80% (Sum of Diastereomers)
Water Content (KF)	Contact for details
Residual Solvents (GC)	Meets ICH guidelines

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