Description

5-Hydroxy Rosiglitazone is a key metabolite and synthetic intermediate of the thiazolidinedione-class antidiabetic drug, Rosiglitazone. This compound is of significant value for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of novel therapeutic agents. It is primarily utilized by research institutions, pharmaceutical companies, and contract development and manufacturing organizations (CDMOs) engaged in metabolic pathway analysis and advanced active pharmaceutical ingredient (API) synthesis.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the quantitative and qualitative analysis of Rosiglitazone and its metabolites in biological matrices.
• Metabolite Research: Essential for in vitro and in vivo studies investigating the metabolic fate, bioavailability, and clearance mechanisms of Rosiglitazone.
• API Synthesis Intermediate: Used as a high-purity building block in the multi-step synthesis of Rosiglitazone and its structural analogs.
• Impurity Profiling: Employed as an impurity marker to monitor and control the quality of Rosiglitazone API batches during manufacturing, ensuring compliance with ICH guidelines.
• Biochemical Assay Development: Utilized in the development and validation of high-throughput screening (HTS) assays and diagnostic kits related to PPARγ receptor activity.
• Toxicology Studies: Applied in safety and toxicology assessments to understand the profile of Rosiglitazone metabolites.

Basic Information

Product Name	5-Hydroxy Rosiglitazone
CAS No.	257883-22-0
Molecular Formula	C18H19N3O3S
Molecular Weight	357.43 g/mol
Synonyms	5-Hydroxyrosiglitazone; 5-Hydroxy Rosiglitazone Maleate (salt form); 5-OH-Rosiglitazone; Rosiglitazone Metabolite M1; 5-Hydroxy-5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione; BVT.935; BRL 49653 Metabolite
EINECS	Contact for details

Quality Control

Our 5-Hydroxy Rosiglitazone is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency suitable for research and development. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to relevant industry standards and can support development projects requiring material produced under current Good Manufacturing Practice (cGMP) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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