Description

Carvedilol Ketone Impurity is a key pharmaceutical reference standard used in the quality control and analytical development of Carvedilol, a widely prescribed β-blocker. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a marker for a specific synthetic pathway impurity. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the ketone impurity in Carvedilol active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Carvedilol meets stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B) for related substances.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), New Drug Applications (NDAs), and other regulatory documentation.
• Research & Development: Serves as a critical tool in process chemistry R&D to optimize synthesis routes and minimize impurity generation.

Basic Information

Product Name	Carvedilol Ketone Impurity
CAS No.	933442-50-3
Molecular Formula	C24H26N2O4
Molecular Weight	406.48 g/mol
Synonyms	1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanone; Carvedilol Impurity K; Carvedilol Ketone; Carvedilol Related Compound K; (RS)-1-(Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-one; UNII-2Q5K2V8H4F; 2-Propanone, 1-(9H-carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-
EINECS	Contact for details

Quality Control

Our Carvedilol Ketone Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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