Description

Rosiglitazone-5-Sulfoxy is a key sulfated metabolite and a significant reference standard for the pharmaceutical compound Rosiglitazone. This high-purity chemical is essential for analytical research, method development, and quality control processes in drug development and manufacturing. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality assurance departments for precise quantification and metabolic studies.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the quantification of Rosiglitazone and its metabolites in biological matrices and pharmaceutical formulations.
• Metabolite Identification & Profiling: Used in in vitro and in vivo ADME (Absorption, Distribution, Metabolism, Excretion) studies to understand the metabolic pathway of Rosiglitazone.
• Bioanalytical Method Development: Essential for developing and validating sensitive HPLC, LC-MS, and LC-MS/MS methods for pharmacokinetic and bioequivalence studies.
• Quality Control & Impurity Testing: Employed as an impurity marker and system suitability standard to ensure the purity and consistency of Rosiglitazone active pharmaceutical ingredient (API) and finished drug products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of identity and quantification for metabolite-related specifications.

Basic Information

Product Name	Rosiglitazone-5-Sulfoxy
CAS No.	288853-63-4
Molecular Formula	C18H19N3O7S2
Molecular Weight	453.49 g/mol
Synonyms	Rosiglitazone 5-Sulfate; Rosiglitazone Sulfate Metabolite; 5-O-Sulfo Rosiglitazone; Rosiglitazone Sulfoxy; 5-[[4-[2-(Methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione 5-Sulfate; BRL 49653 Sulfate Metabolite; Avandia Metabolite (Sulfate)
EINECS	Contact for details

Quality Control

Our Rosiglitazone-5-Sulfoxy 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 comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established in-house reference standards. Our quality commitment ensures material suitable for demanding pharmaceutical R&D and regulatory applications.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant and inert atmosphere to ensure stability.

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.