Description

Carvedilol Impurity Coh CAS NO 51997-50-3 is a high-purity chemical reference standard used in pharmaceutical development and quality control. This compound is critical for ensuring the safety and efficacy of Carvedilol, a widely prescribed β-blocker medication, by enabling the accurate identification and quantification of related substances. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical manufacturing, research laboratories, and regulatory compliance sectors.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Coh impurity in Carvedilol active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity characterization.
• Stability Studies: Used to track the formation of degradation products in Carvedilol formulations under various stress conditions (heat, light, humidity).
• Research and Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and metabolic pathways of Carvedilol.

Basic Information

Product Name	Carvedilol Impurity Coh
CAS No.	51997-50-3
Molecular Formula	C24H26N2O4
Molecular Weight	406.48 g/mol
Synonyms	1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol; Carvedilol Impurity C; Carvedilol Related Compound Coh; 4-[3-[[2-(2-Methoxyphenoxy)ethyl]amino]-2-hydroxypropoxy]-9H-carbazole; UNII-9FQ6S6A2CX
EINECS	Contact for details

Quality Control

Every batch of Carvedilol Impurity Coh is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to specified 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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.