Description

Hydroxy Pioglitazone (m-Vii) β-D-Glucuronide is a high-purity reference standard and metabolite of the thiazolidinedione-class antidiabetic drug, Pioglitazone. This compound is of critical importance for pharmaceutical research and development, particularly in the fields of drug metabolism and pharmacokinetics (DMPK) studies. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in bioanalytical method development, metabolite identification, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the quantitative and qualitative analysis of Pioglitazone metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK): Essential for in vitro and in vivo studies to understand the metabolic pathway, clearance, and exposure of Pioglitazone.
• Bioanalytical Method Development: Used to develop and validate sensitive LC-MS/MS or HPLC-UV methods for therapeutic drug monitoring and pharmacokinetic profiling.
• Impurity Profiling: Acts as a known impurity or degradation product standard for quality control of Pioglitazone active pharmaceutical ingredient (API) and finished dosage forms.
• Clinical Research: Supports clinical trial studies by enabling accurate measurement of metabolite levels in patient plasma or serum samples.
• Regulatory Submissions: Provides critical data for Investigational New Drug (IND) and New Drug Application (NDA) filings to health authorities like the FDA and EMA.

Basic Information

Product Name	Hydroxy Pioglitazone (m-Vii) β-D-Glucuronide
CAS No.	625853-75-0
Molecular Formula	C28H33NO11S
Molecular Weight	591.63 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione M7 Glucuronide; Pioglitazone Metabolite M7 Glucuronide; Hydroxy Pioglitazone Glucuronide; KRP-297 Metabolite; AD-4833 Metabolite; U-72107A Metabolite; (m-VII) Metabolite
EINECS	Contact for details

Quality Control

Our Hydroxy Pioglitazone (m-Vii) β-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. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white powder
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.