Description

Pioglitazone Sulfonic Acid Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Pioglitazone, a medication used to treat type 2 diabetes. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling. The precise characterization of this impurity is fundamental for maintaining the highest standards in drug manufacturing and quality control.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor the sulfonic acid derivative impurity in Pioglitazone API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), and mass spectrometry (MS) methods.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to ensure Pioglitazone batches meet stringent pharmacopeial (e.g., USP, EP, ICH) specifications for impurity limits.
• Stability Studies and Forced Degradation Testing: Acts as a marker to study the degradation pathways and stability profile of Pioglitazone under various stress conditions.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development (R&D): Utilized in synthetic chemistry and pharmaceutical R&D to understand impurity formation mechanisms and optimize synthesis processes.

Basic Information

Product Name	Pioglitazone Sulfonic Acid Impurity
CAS No.	625853-73-8
Molecular Formula	C19H20N2O6S
Molecular Weight	404.44 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione Sulfonic Acid Derivative; Pioglitazone Sulfonate Impurity; Pioglitazone Related Compound; Pioglitazone Sulfonic Acid Analog; AD-4833 Sulfonic Acid Impurity; U-72107A Sulfonic Acid Impurity; Actos Sulfonic Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Pioglitazone Sulfonic Acid Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider conditions as recommended on the specific Certificate of Analysis.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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