Description

4-[2-(5-Ethyl-2-Pyridinyl)Ethoxy]Benzenepropanoic Acid Ethyl Ester is a critical pharmaceutical reference standard and impurity used in the development and quality control of the antidiabetic drug Pioglitazone. This compound is essential 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 research institutions focused on diabetes treatment and API synthesis.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods in QC/QA laboratories.
• Impurity Profiling & Control: Used for the identification, quantification, and monitoring of this specific impurity during Pioglitazone Active Pharmaceutical Ingredient (API) synthesis and formulation.
• Method Development & Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and LC-MS, for Pioglitazone drug products.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Pioglitazone.
• Research & Development: Used in synthetic chemistry research to study metabolic pathways or to develop improved synthetic routes for thiazolidinedione-class drugs.

Basic Information

Product Name	4-[2-(5-Ethyl-2-Pyridinyl)Ethoxy]Benzenepropanoic Acid Ethyl Ester (Pioglitazone Impurity)
CAS No.	868754-42-1
Molecular Formula	C20H25NO3
Molecular Weight	327.42 g/mol
Synonyms	Ethyl 4-[2-(5-ethylpyridin-2-yl)ethoxy]benzenepropanoate; Pioglitazone Ethyl Ester Impurity; Pioglitazone Related Compound; 5-Ethyl-2-[2-(4-(2-ethoxy-2-oxoethyl)phenoxy)ethyl]pyridine; Ethyl 3-[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]propanoate; ACTOS Impurity; AD-4833 Impurity
EINECS	Contact for details

Quality Control

Our 4-[2-(5-Ethyl-2-Pyridinyl)Ethoxy]Benzenepropanoic Acid Ethyl Ester is manufactured under strict quality systems suitable for pharmaceutical impurity analysis. Each batch is subjected to rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, NMR), to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), 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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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