Description

4-Hydroxy Duloxetine B-D-Glucuronide is a key phase II metabolite of the widely prescribed antidepressant duloxetine. This compound is of significant importance for pharmaceutical research and development, particularly in the fields of drug metabolism and pharmacokinetics (DMPK) studies. It serves as a critical reference standard for analytical laboratories, enabling accurate quantification and characterization of duloxetine metabolism in biological samples. Professionals in pharmaceutical R&D, contract research organizations (CROs), and regulatory affairs require this high-purity metabolite to ensure drug safety and efficacy profiles.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the calibration of analytical instruments in bioanalytical studies.
• Drug Metabolism and Pharmacokinetics (DMPK): Essential for in vitro and in vivo studies to understand the metabolic pathway, clearance, and exposure of duloxetine.
• Bioanalytical Method Development & Validation: Used to develop and validate precise HPLC, LC-MS, or LC-MS/MS methods for quantifying duloxetine and its metabolites in plasma, serum, or urine.
• Toxicology and Safety Assessment: Supports studies investigating the safety profile and potential toxicological implications of duloxetine metabolites.
• Clinical Research: Aids in clinical trials for monitoring patient metabolite levels, assessing inter-individual variability, and supporting regulatory submissions.
• Academic Research: Used in university and institutional labs for pharmacological studies related to serotonin-norepinephrine reuptake inhibitors (SNRIs).

Basic Information

Product Name	4-Hydroxy Duloxetine B-D-Glucuronide
CAS No.	741693-83-4
Molecular Formula	C24H28NO8S
Molecular Weight	490.55 g/mol
Synonyms	4-Hydroxy Duloxetine Glucuronide; Duloxetine 4-O-Glucuronide; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(4-hydroxythiophen-2-yl)propan-1-amine Glucuronide; Duloxetine Metabolite; LY248686 Glucuronide; (+)-(S)-Duloxetine 4-O-β-D-Glucuronide; 4-OH Duloxetine Glucuronide
EINECS	Contact for details

Quality Control

Our 4-Hydroxy Duloxetine B-D-Glucuronide is manufactured under strict quality systems suitable for research and analytical applications. Each batch undergoes rigorous analytical testing, including HPLC for purity and spectroscopic methods for structural confirmation, to ensure identity, potency, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected by pharmaceutical and analytical laboratories 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 product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥95.0%
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.