Description

Pioglitazone Ep Impurity G 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 primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in method development, validation, and impurity profiling to meet stringent pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of a specific impurity in Pioglitazone API and its formulations.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure API purity complies with ICH Q3A/B guidelines and pharmacopeia monographs.
• Regulatory Compliance and Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Research and Development: Used in synthetic chemistry and pharmacology research to study the metabolism, degradation pathways, and toxicology of Pioglitazone.

Basic Information

Product Name	Pioglitazone Ep Impurity G
CAS No.	952187-99-4
Molecular Formula	C19H20N2O3S
Molecular Weight	356.44 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, S-Oxide; Pioglitazone EP Impurity G; Pioglitazone Sulfoxide; Pioglitazone Related Compound G; Pioglitazone Sulfoxide Impurity; ACTOS Impurity G; TZD Sulfoxide Derivative
EINECS	Contact for details

Quality Control

Every batch of Pioglitazone Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Assay	97.0% - 102.0% (on dried basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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