Description

Pioglitazone Impurity 5 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, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards and supporting robust drug development processes.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of impurities in Pioglitazone API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Pioglitazone.
• Pharmacopeial Testing: Supports testing in compliance with monographs from USP, EP, or other international pharmacopeias.

Basic Information

Product Name	Pioglitazone Impurity 5
CAS No.	1526933-30-1
Molecular Formula	C₁₉H₂₀N₂O₃S
Molecular Weight	356.44 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione; Pioglitazone Related Compound; Pioglitazone EP Impurity; Pioglitazone USP Impurity; Thiazolidinedione derivative; 5-Ethyl-2-[2-[[4-[(2,4-thiazolidinedion-5-yl)methyl]phenoxy]ethyl]]pyridine
EINECS	Contact for details

Quality Control

Every batch of Pioglitazone Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling 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, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.