Description

Pioglitazone Ep Impurity F 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Pioglitazone API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to meet ICH guidelines.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and batch release to ensure drug substance purity and compliance with pharmacopeial standards (USP, EP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to monitor the formation of degradation products in Pioglitazone formulations under various storage conditions.
• Research & Development: Used in synthetic chemistry and metabolic studies to understand impurity formation pathways and degradation mechanisms.

Basic Information

Item	Detail
Product Name	Pioglitazone Ep Impurity F
CAS No.	1391052-15-5
Molecular Formula	C19H20N2O3S
Molecular Weight	356.44 g/mol
Synonyms	Pioglitazone Impurity F; Pioglitazone EP Impurity F; 5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione Impurity; Thiazolidinedione derivative impurity; Pioglitazone Related Compound F; Pioglitazone Process Impurity; 5-[[4-[2-(5-Ethylpyridin-2-yl)ethoxy]phenyl]methyl]thiazolidine-2,4-dione impurity
EINECS	Contact for details

Quality Control

Our Pioglitazone Ep Impurity F is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We ensure compliance with relevant pharmacopeial guidelines for impurity reference standards.

Storage

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

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%
Residue on Ignition	≤ 0.1%

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