Description

Hydroxy Pioglitazone (m-Vii) is a key pharmaceutical intermediate and reference standard, specifically a metabolite of the thiazolidinedione-class antidiabetic drug Pioglitazone. Its primary value lies in enabling critical research and development, including metabolic pathway studies, pharmacokinetic analysis, and the synthesis of novel therapeutic agents. This high-purity compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on diabetes treatment and drug discovery.

Application

• Pharmaceutical Intermediate: Used in the synthesis and process development of Pioglitazone and related thiazolidinedione derivatives.
• Metabolite Reference Standard: Serves as a critical analytical standard for quantifying Pioglitazone metabolites in bioanalytical studies (plasma, urine) during clinical trials and pharmacokinetic research.
• Drug Impurity Profiling: Employed as a certified reference material to identify, quantify, and control related substance impurities in active pharmaceutical ingredient (API) batches.
• Biochemical Research: Utilized in in-vitro and in-vivo studies to investigate the mechanisms of action, metabolic pathways, and safety profiles of insulin-sensitizing drugs.
• Quality Control & Assurance: Acts as a system suitability standard in HPLC and LC-MS/MS methods for ensuring the accuracy and precision of analytical procedures in QC laboratories.

Basic Information

Product Name	Hydroxy Pioglitazone (m-Vii)
CAS No.	625853-72-7
Molecular Formula	C19H20N2O3S
Molecular Weight	356.44 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, M-VII metabolite of Pioglitazone; Hydroxylated Pioglitazone; Pioglitazone Hydroxy Metabolite; Pioglitazone Metabolite M7; KRP-297 Metabolite; AD-4833 Metabolite
EINECS	Contact for details

Quality Control

Our Hydroxy Pioglitazone (m-Vii) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets stringent specifications for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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