Description

Pioglitazone n-β-D-Glucuronide is a major, pharmacologically relevant metabolite of the thiazolidinedione antidiabetic drug Pioglitazone. This compound is critical for pharmaceutical research and development, serving as a primary reference standard for drug metabolism and pharmacokinetic (DMPK) studies. It is essential for scientists and quality control laboratories in the pharmaceutical and biotechnology industries who require high-purity analytical standards for bioanalytical method development, clinical trial support, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative and qualitative analysis of Pioglitazone and its metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK): Critical for in vitro and in vivo studies to understand the metabolic pathway, clearance, and exposure of Pioglitazone.
• Bioanalytical Method Development & Validation: Used as a key calibrator and quality control sample in LC-MS/MS and HPLC methods for therapeutic drug monitoring and pharmacokinetic assays.
• Clinical Research & Toxicology: Supports clinical trials by enabling accurate measurement of drug metabolite levels in patient plasma, serum, or urine samples.
• Impurity Profiling & Characterization: Employed in the identification and quantification of glucuronide conjugate impurities in active pharmaceutical ingredient (API) batches.
• Regulatory Submissions: Provides essential data for Investigational New Drug (IND) and New Drug Application (NDA) filings to health authorities like the FDA and EMA.

Basic Information

Product Name	Pioglitazone n-β-D-Glucuronide
CAS No.	1296832-75-1
Molecular Formula	C26H31NO10S
Molecular Weight	549.59 g/mol
Synonyms	Pioglitazone N-Glucuronide; Pioglitazone Glucuronide; 5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione N-Glucuronide; AD-4833 Glucuronide; U-72107A Glucuronide; Pioglitazone β-D-Glucuronide; Pioglitazone Metabolite M7; (2S,3S,4S,5R,6S)-6-(5-((4-(2-(5-Ethylpyridin-2-yl)ethoxy)benzyl)thiazolidine-2,4-dione-3-yl)oxy)-3,4,5-trihydroxytetrahydro-2H-pyran-2-carboxylic acid
EINECS	Contact for details

Quality Control

Our Pioglitazone n-β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC (purity), LC-MS (identity confirmation), and NMR spectroscopy, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. For short-term use, the material may be stored at 2-8°C. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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