Description

n-Desmethyl Rosiglitazone is a key pharmaceutical intermediate and metabolite of the antidiabetic drug rosiglitazone. This compound is of significant value for research and development in the fields of pharmacology and analytical chemistry. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in metabolic studies, bioanalytical method development, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the quantification and identification of rosiglitazone metabolites in biological matrices during pharmacokinetic studies.
• Metabolite Research: Used in in vitro and in vivo studies to understand the metabolic pathways, efficacy, and safety profile of rosiglitazone.
• Impurity Profiling: Essential for the development and validation of analytical methods (e.g., HPLC, LC-MS) to monitor and control process-related impurities in rosiglitazone active pharmaceutical ingredient (API) manufacturing.
• Drug Discovery & Development: Acts as a building block or a tool compound in the synthesis and evaluation of new thiazolidinedione analogs for treating type 2 diabetes and related metabolic disorders.
• Bioanalytical Assay Development: Employed as a calibration standard to ensure accuracy and precision in bioequivalence and clinical trial sample analysis.
• Regulatory Compliance Testing: Supports compliance with ICH guidelines (Q3A, Q3B) for the characterization and reporting of degradation products and metabolites in regulatory submissions.

Basic Information

Product Name	n-Desmethyl Rosiglitazone
CAS No.	257892-31-2
Molecular Formula	C17H19N3O3S
Molecular Weight	345.42 g/mol
Synonyms	5-[[4-[2-(Methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione; Desmethyl Rosiglitazone; Rosiglitazone N-Desmethyl Metabolite; Rosiglitazone Metabolite; BRL 49653 Metabolite; 2,4-Thiazolidinedione, 5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-; 257892-31-2
EINECS	Contact for details

Quality Control

Our n-Desmethyl Rosiglitazone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with relevant standards for pharmaceutical intermediates and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
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.