Description

Rosiglitazone Related Compound A (25 Mg) ((5Z)-5-{[4-({2-[Methyl(2-Pyridinyl)Amino]Ethyl}Oxy)Phenyl]Methylidene}-1,3-Thiazolidine-2,4-Dione) is a high-purity chemical reference standard essential for pharmaceutical research and quality control. This compound serves as a critical impurity marker and analytical standard for the development and validation of methods related to the antidiabetic drug Rosiglitazone. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug development and regulatory compliance. The product is supplied in a 25 mg quantity, ideal for precise laboratory use and method development.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Rosiglitazone API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure specificity, accuracy, and precision.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Used to track the formation of degradation products in Rosiglitazone formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Pharmacological Research: Acts as a tool in metabolic and pharmacokinetic studies to understand the drug's behavior and potential interactions.

Basic Information

Item	Details
Product Name	Rosiglitazone Related Compound A (25 Mg) ((5Z)-5-{[4-({2-[Methyl(2-Pyridinyl)Amino]Ethyl}Oxy)Phenyl]Methylidene}-1,3-Thiazolidine-2,4-Dione)
CAS No.	160596-25-8
Molecular Formula	C19H19N3O3S
Molecular Weight	369.44 g/mol
Synonyms	(5Z)-5-{[4-({2-[Methyl(2-Pyridinyl)Amino]Ethyl}Oxy)Phenyl]Methylidene}-1,3-Thiazolidine-2,4-Dione; Rosiglitazone Impurity A; Rosiglitazone Related Substance A; 5-[[4-[2-(N-Methyl-N-(2-pyridyl)amino)ethoxy]phenyl]methylene]thiazolidine-2,4-dione (Z-isomer); BVT.12777; Avandia Impurity A
EINECS	Contact for details

Quality Control

Our Rosiglitazone Related Compound A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing results from HPLC purity assay, related substances, and spectroscopic identification (IR, NMR, MS). Our quality commitment aligns with ICH Q3A, Q3B, and Q6A guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
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%
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.