Description

Doxepin-n-β-D-Glucuronide is a major, stable metabolite of the tricyclic antidepressant doxepin, formed via glucuronidation. This compound is of critical importance as a certified reference standard for accurate analytical quantification in pharmacokinetic and bioequivalence studies. It is essential for laboratories in the pharmaceutical, forensic toxicology, and clinical research sectors requiring precise calibration for LC-MS/MS and HPLC methods to ensure regulatory compliance and data integrity.

Application

• Pharmaceutical Reference Standard: Primary use as a high-purity certified reference material (CRM) for the quantification of doxepin and its metabolites in biological matrices.
• Bioanalytical Method Development & Validation: Critical for developing, calibrating, and validating sensitive LC-MS/MS, HPLC-UV, and UPLC assays in clinical and preclinical studies.
• Pharmacokinetic & Metabolism Studies: Used to study the metabolic pathways, clearance rates, and bioavailability of doxepin in human and animal models.
• Forensic Toxicology & Doping Control: Serves as an essential standard for the accurate identification and quantification of doxepin in forensic and anti-doping laboratories.
• Quality Control in Drug Manufacturing: Employed in impurity profiling and stability testing of doxepin-based pharmaceutical formulations.
• Academic & Contract Research: Used in universities and CROs for research on drug metabolism, enzyme activity (UGT), and biochemical pathways.

Basic Information

Product Name	Doxepin-n-β-D-Glucuronide
CAS No.	1075185-73-7
Molecular Formula	C25H31NO8
Molecular Weight	473.52 g/mol
Synonyms	Doxepin N-Glucuronide; Doxepin Glucuronide; Doxepin N-β-D-Glucuronide; Doxepin N-β-Glucuronide; (E)-Doxepin N-Glucuronide; 1-{3-[(E)-{3-[(Dimethylamino)propyl]oxy}phenyl]-1-oxido-3H-benzo[b][1,4]oxazepin-11-yl}-β-D-glucopyranuronic acid; Doxepin Metabolite Glucuronide
EINECS	Contact for details

Quality Control

Our Doxepin-n-β-D-Glucuronide is manufactured under strict quality systems suitable for reference standard applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data. We ensure compliance with relevant industry standards, and our quality protocols are designed to support GMP/GLP-aligned research and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This hygroscopic (moisture-sensitive) compound should be allowed to equilibrate to room temperature in a desiccator before opening to prevent moisture uptake. For short-term use, storage at 2-8°C is acceptable.

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)	Complies with ICH guidelines

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