Description

Pioglitazone Aldehyde Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antidiabetic drug Pioglitazone. This high-purity impurity is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within pharmaceutical companies and contract research organizations (CROs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development, validation, and routine quality control testing of Pioglitazone API and finished dosage forms.
• Impurity Profiling and Identification: Critical for identifying and quantifying the Pioglitazone Aldehyde impurity in stability studies and release testing to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submission and Compliance: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing a characterized impurity for inclusion in drug master files (DMFs) and marketing authorization applications.
• Research and Development (R&D): Used in synthetic route optimization and degradation studies to understand the formation and control of this specific process-related impurity.
• Calibration and System Suitability: Serves as a system suitability test component in High-Performance Liquid Chromatography (HPLC) and LC-MS methods to ensure analytical instrument performance.

Basic Information

Product Name	Pioglitazone Aldehyde Impurity
CAS No.	856255-80-6
Molecular Formula	C₁₉H₂₀N₂O₃S
Molecular Weight	356.44 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione-5-carboxaldehyde; Pioglitazone Related Compound Aldehyde; Pioglitazone EP Impurity F; Pioglitazone Aldehyde; 5-Formyl Pioglitazone; 5-Carbaldehyde Derivative of Pioglitazone; Thiazolidinedione Aldehyde Impurity
EINECS	Contact for details

Quality Control

Every batch of our Pioglitazone Aldehyde Impurity is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques, including NMR, Mass Spectrometry, and HPLC, to ensure high purity and structural identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, impurity profile, and analytical results. Our quality standards align with the requirements for pharmaceutical reference materials.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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