Description

Pioglitazone Hydrochloride is the hydrochloride salt of a potent thiazolidinedione-class insulin sensitizer. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of effective anti-diabetic medications. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for type 2 diabetes mellitus.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral anti-diabetic tablets and formulations.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in pharmaceutical labs.
• Research & Development: Used in preclinical and clinical studies investigating insulin resistance and metabolic syndrome pathways.
• Generic Drug Manufacturing: Essential for the production of generic versions of pioglitazone-based medications following patent expiry.
• Formulation Development: Employed in the development of novel drug delivery systems, such as sustained-release formulations.

Basic Information

Product Name	Pioglitazone Hydrochloride
CAS No.	112529-15-4
Molecular Formula	C19H21ClN2O3S
Molecular Weight	392.90 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione Hydrochloride; AD-4833 Hydrochloride; U-72107A; Actos (brand name reference); Pioglitazone HCl; Pioglitazone Monohydrochloride; (±)-Pioglitazone Hydrochloride
EINECS	Contact for details

Quality Control

Our Pioglitazone Hydrochloride is manufactured under strict quality management systems. It is typically produced to meet pharmaceutical-grade standards, with specifications aligned with major pharmacopoeias. Comprehensive testing includes identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) is provided with each batch to ensure traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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