Description

Hydroxy Pioglitazone (m-Iv) β-D-Glucuronide is a key 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 serves as an essential reference standard for analytical laboratories in pharmaceutical companies, contract research organizations (CROs), and academic institutions. The availability of high-purity metabolite standards is vital for ensuring accurate bioanalytical method development and regulatory compliance in drug safety assessment.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantification of Pioglitazone metabolites in biological matrices during clinical and pre-clinical trials.
• Drug Metabolism and Pharmacokinetics (DMPK): Critical for in vitro and in vivo studies to understand the metabolic pathway, clearance, and exposure of Pioglitazone.
• Bioanalytical Method Development and Validation: Used to develop, optimize, and validate sensitive LC-MS/MS or HPLC-UV methods for pharmacokinetic analysis.
• Toxicology and Safety Assessment: Employed in studies to correlate metabolite levels with efficacy and potential safety signals.
• Impurity Profiling and Characterization: Acts as a known impurity standard for quality control 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 metabolite identification and quantification data.

Basic Information

Product Name	Hydroxy Pioglitazone (m-Iv) β-D-Glucuronide
CAS No.	625853-76-1
Molecular Formula	C28H34NO11S
Molecular Weight	592.64 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione M-IV β-D-Glucuronide; Pioglitazone Metabolite M-IV Glucuronide; Hydroxy Pioglitazone Glucuronide; KTP-β-D-Glucuronide (M-IV); 5-{4-[2-(5-Ethylpyridin-2-yl)ethoxy]benzyl}thiazolidine-2,4-dione M-IV β-D-Glucuronide; AD-4833 Glucuronide Metabolite
EINECS	Contact for details

Quality Control

Our Hydroxy Pioglitazone (m-Iv) β-D-Glucuronide is manufactured under strict quality systems suitable for pharmaceutical research. Each batch undergoes rigorous identity confirmation, purity analysis, and stability testing. We provide comprehensive Certificates of Analysis (COA) detailing results from advanced analytical techniques including HPLC, LC-MS, and NMR to ensure traceability and batch-to-batch consistency. Our quality commitment supports compliance with ICH guidelines for impurities and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and must be handled under dry, inert conditions to maintain stability. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

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)	Complies with ICH Q3C

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