Description

Carvedilol Tetrakisalkylpyrocatechol Impurity is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Carvedilol, a non-selective β-blocker. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Carvedilol API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Carvedilol under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity control and adherence to ICH Q3A/B guidelines.
• Process Chemistry Research: Used in R&D to understand and control the formation of this impurity during the synthesis and purification stages of Carvedilol manufacturing.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure API purity and specification compliance.

Basic Information

Product Name	Carvedilol Tetrakisalkylpyrocatechol Impurity
CAS No.	1391052-20-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carvedilol Tetrakisalkylpyrocatechol Related Compound; Carvedilol Process Impurity; Carvedilol Degradant; Tetrakisalkylpyrocatechol Derivative of Carvedilol; Carvedilol Impurity T; Carvedilol Related Substance A (context-specific); Carvedilol Analog; 1391052-20-2
EINECS	Contact for details

Quality Control

Our Carvedilol Tetrakisalkylpyrocatechol Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods (NMR, MS) for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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