Description

Carvedilol Impurity 4 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 studies. Ensuring the identity and purity of such impurities is fundamental to drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Carvedilol active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure Carvedilol products meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Carvedilol Impurity 4
CAS No.	72955-96-5
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 D; Carvedilol EP Impurity D; Carvedilol USP Related Compound D; 4-[[2-Hydroxy-3-[[2-(2-methoxyphenoxy)ethyl]amino]propoxy]-9H-carbazole; UNII-2R9Q7M1C4H
EINECS	Contact for details

Quality Control

Every batch of Carvedilol Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and spectroscopic methods for structural confirmation, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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.