Description

Carvedilol Impurity 2 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Carvedilol, a widely prescribed β-blocker medication. It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and impurity profiling. Ensuring the integrity of the active pharmaceutical ingredient requires precise identification and quantification of related substances like this impurity.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for calibrating analytical instruments and validating testing methods for Carvedilol.
• Impurity Profiling and Identification: Essential for identifying and quantifying this specific impurity in Carvedilol drug substances and finished products to meet ICH guidelines.
• Method Development and Validation: Serves as a key component in developing and validating HPLC, UPLC, or LC-MS methods for stability-indicating assays.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels and ensure batch-to-batch consistency of Carvedilol.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Stability Studies: Used to track the formation of this impurity under various stress conditions (heat, light, humidity) as part of drug stability programs.
• Research and Development: Aids in synthetic route optimization and degradation pathway studies during the drug development process.

Basic Information

Product Name	Carvedilol Impurity 2
CAS No.	1198090-71-9
Molecular Formula	C24H26N2O4
Molecular Weight	406.48 g/mol
Synonyms	1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol; Carvedilol Related Compound B; Carvedilol EP Impurity B; Carvedilol USP Related Compound B; 4-[3-[[2-(2-Methoxyphenoxy)ethyl]amino]-2-hydroxypropoxy]-9H-carbazole; UNII-8Q3KQN5Z6P
EINECS	Contact for details

Quality Control

Our Carvedilol Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, impurity profile, and analytical results. The material is suitable for use in compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.