Description

Pioglitazone Thiazolidinedione Ring-Opened n-β-D-Glucuronide is a major, pharmacologically relevant Phase II metabolite of the antidiabetic drug pioglitazone. This compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK/PD), and the development of analytical reference standards. It is essential for scientists and organizations involved in bioanalytical method development, metabolite identification, and regulatory compliance testing for generic or novel drug formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantitative and qualitative analysis in drug development and quality control laboratories.
• Metabolite Research & Identification: Crucial for in vitro and in vivo studies to understand the metabolic pathways and biological activity of pioglitazone.
• Bioanalytical Method Development: Used to develop and validate sensitive LC-MS/MS, HPLC, or UPLC methods for the detection and quantification of pioglitazone metabolites in biological matrices.
• DMPK (Drug Metabolism and Pharmacokinetics) Studies: Serves as a key analyte in absorption, distribution, metabolism, and excretion (ADME) profiling.
• Impurity Profiling: Acts as a specified impurity or degradation product standard for the analytical characterization of pioglitazone active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Submissions: Supports investigational new drug (IND) and new drug application (NDA) filings by providing definitive characterization data for major human metabolites.

Basic Information

Product Name	Pioglitazone Thiazolidinedione Ring-Opened n-β-D-Glucuronide
CAS No.	1296832-76-2
Molecular Formula	C24H28NO9S
Molecular Weight	506.55 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione 1-β-D-Glucuronide; M-IV Metabolite of Pioglitazone; Pioglitazone Thiazolidinedione Ring-Opened Glucuronide; Pioglitazone Metabolite M4; Pioglitazone 1-β-D-Glucuronide; Ring-Opened Thiazolidinedione Glucuronide of Pioglitazone; AD-4833 Glucuronide
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality control conditions. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for purity, impurities, and analytical data. Our quality system is designed to support GMP/GLP-compliant research and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This compound is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture condensation. For long-term storage, consider under an inert atmosphere.

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)	Meets ICH guidelines

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