Description

Carvedilol Bis-Carbazole is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of Carvedilol, a widely prescribed non-selective β-blocker and α-blocker. Its precise chemical structure makes it essential for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). This high-purity compound is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, process optimization, and regulatory compliance testing.

Application

• Pharmaceutical Intermediate: A critical building block in the multi-step synthesis of the Carvedilol API.
• Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Carvedilol drug substances and products.
• Impurity Profiling: Essential for method development and validation in HPLC and LC-MS analyses to monitor and control process-related impurities.
• Regulatory Compliance: Supports filings with agencies like the FDA and EMA by providing a characterized impurity standard for stability studies and specification setting.
• Research & Development: Used in academic and industrial R&D to study Carvedilol metabolism, degradation pathways, and to develop novel synthetic routes.
• Quality Control Laboratories: Employed in in-house QC testing to ensure batch-to-batch consistency and adherence to pharmacopeial standards (USP, EP).

Basic Information

Product Name	Carvedilol Bis-Carbazole
CAS No.	918903-20-5
Molecular Formula	C48H50N4O6
Molecular Weight	778.94 g/mol
Synonyms	1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol Bis-Carbazole Impurity; Carvedilol Carbazole Dimer; Carvedilol Impurity K (EP); Carvedilol Related Compound K; Bis(1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol); 4,4'-[2-Hydroxy-3-[[2-(2-methoxyphenoxy)ethyl]amino]propoxy]dicarbozole
EINECS	Contact for details

Quality Control

Our Carvedilol Bis-Carbazole is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets stringent standards for use as a pharmaceutical reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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.