Description

5-Hydroxy Rosiglitazone B-D-Glucuronide is a key metabolite of the thiazolidinedione-class antidiabetic drug, rosiglitazone. This compound is of significant importance in pharmaceutical research and development, primarily for use as a reference standard in bioanalytical studies. It is essential for scientists and quality control professionals in the pharmaceutical and contract research organization (CRO) sectors who require high-purity materials for pharmacokinetic profiling, metabolic pathway elucidation, and regulatory method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative and qualitative analysis of rosiglitazone metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Critical for in vitro and in vivo studies to understand the metabolic fate, clearance, and exposure of rosiglitazone.
• Bioanalytical Method Development & Validation: Serves as a critical standard for developing and validating robust LC-MS/MS, HPLC, or UPLC methods in compliance with FDA, EMA, or ICH guidelines.
• Clinical Research: Used in clinical trial sample analysis to monitor metabolite levels and ensure patient safety and drug efficacy.
• Toxicology Studies: Employed in investigative studies to assess the safety profile and potential toxicological implications of rosiglitazone's major metabolites.
• Impurity Profiling: Acts as an identified impurity or degradation product standard in the quality control of rosiglitazone active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	5-Hydroxy Rosiglitazone B-D-Glucuronide
CAS No.	288853-59-8
Molecular Formula	C24H27N3O9S
Molecular Weight	533.55 g/mol
Synonyms	5-Hydroxyrosiglitazone Glucuronide; Rosiglitazone Metabolite; 5-Hydroxy Rosiglitazone Glucuronide; 5-Hydroxy Rosiglitazone β-D-Glucuronide; BRL 49653 Metabolite; 5-Hydroxy-4-[2-[methyl(pyridin-2-yl)amino]ethoxy]benzyl]thiazolidine-2,4-dione glucuronide; Avandia Metabolite
EINECS	Contact for details

Quality Control

Our 5-Hydroxy Rosiglitazone B-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment. Allow the vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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