Description

4-[2-(Methyl-2-Pyridinylamino)Ethoxy]Benzenepropanamide (Rosiglitazone Impurity) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critically important for pharmaceutical quality control, specifically in the development and validation of analytical methods for the antidiabetic drug Rosiglitazone. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in impurity profiling, method development, and regulatory compliance testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Rosiglitazone drug substance and finished products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used as a critical standard to develop, optimize, and validate chromatographic methods for impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure compliance with ICH guidelines.
• Regulatory Submission and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed as a marker to track impurity formation in Rosiglitazone formulations under various stress and storage conditions.
• Research and Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Rosiglitazone.

Basic Information

Product Name	4-[2-(Methyl-2-Pyridinylamino)Ethoxy]Benzenepropanamide (Rosiglitazone Impurity)
CAS No.	1797979-55-5
Molecular Formula	C18H23N3O2
Molecular Weight	313.40 g/mol
Synonyms	Rosiglitazone Impurity; 4-[2-(N-Methyl-N-(2-pyridyl)amino)ethoxy]benzenepropanamide; N-(4-[2-(N-Methyl-N-(pyridin-2-yl)amino)ethoxy]phenyl)propanamide; Rosiglitazone Related Compound; Avandia Impurity; BRL 49653 Impurity; 2-{4-[2-(N-Methyl-N-(pyridin-2-yl)amino)ethoxy]phenyl}propanamide (common mis-assignment).
EINECS	Contact for details

Quality Control

Every batch of 4-[2-(Methyl-2-Pyridinylamino)Ethoxy]Benzenepropanamide (Rosiglitazone Impurity) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with stringent pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

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.