Description

Pioglitazone (Potassium Salt) is a high-purity pharmaceutical intermediate and reference standard, specifically the potassium salt form of the thiazolidinedione antidiabetic agent. Its primary value lies in enabling precise research, development, and quality control processes for metabolic disorder therapeutics. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on diabetes treatment and drug metabolism studies.

Application

• Pharmaceutical Active Pharmaceutical Ingredient (API) Synthesis: A key intermediate in the production of Pioglitazone hydrochloride, the active form used in medications.
• Reference Standard for Analytical Testing: Used in HPLC, LC-MS, and other chromatographic methods for method development, validation, and quality control of finished drug products.
• Metabolic Disease Research: A critical tool for in-vitro and in-vivo studies investigating the mechanisms of insulin sensitization and PPAR-γ activation.
• Impurity Profiling and Characterization: Serves as a known standard to identify and quantify related substances and degradation products in pharmaceutical formulations.
• Preclinical and Clinical Trial Material: Used in the preparation of formulations for non-clinical and clinical studies under Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines.
• Regulatory Submission Support: Provides certified material for stability studies and documentation required for drug master files (DMFs) and regulatory filings (e.g., with FDA, EMA).

Basic Information

Product Name	Pioglitazone (Potassium Salt)
CAS No.	1266523-09-4
Molecular Formula	C19H19KN2O3S
Molecular Weight	394.53 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione potassium salt; Pioglitazone potassium; AD-4833 potassium salt; U-72107 potassium salt; Actos (related to hydrochloride salt); Glustin (related to hydrochloride salt); Zactos (related to hydrochloride salt); (±)-Pioglitazone potassium salt
EINECS	Contact for details

Quality Control

Our Pioglitazone (Potassium Salt) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical intermediates and reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and protected from light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm

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