Description

Pioglitazone Impurity CAS NO 952188-00-0 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antidiabetic drug Pioglitazone. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Pioglitazone active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Used to establish and validate chromatographic methods for impurity profiling and assay determination.
• Quality Control & Batch Release Testing: Essential for routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to understand impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Pioglitazone Impurity
CAS No.	952188-00-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pioglitazone Related Compound; Pioglitazone Process Impurity; 5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione Impurity; Thiazolidinedione Derivative Impurity; TZD Impurity; Actos Impurity; AD-4833 Impurity; U-72107A Impurity
EINECS	Contact for details

Quality Control

Every batch of Pioglitazone Impurity (CAS 952188-00-0) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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 solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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