Description

n-Methyl Carvedilol is a key pharmaceutical impurity and analytical reference standard used in the quality control of Carvedilol, a widely prescribed β-blocker medication. This compound is critical for ensuring the purity, safety, and efficacy of Carvedilol drug substances and finished products through precise analytical methods. It is primarily utilized by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions focused on cardiovascular drug development and regulatory compliance. The availability of high-purity n-Methyl Carvedilol is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (CRM) for the identification and quantification of the n-Methyl impurity in Carvedilol active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and related chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure Carvedilol products comply with specified impurity limits per ICH, USP, or EP guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to monitor the formation of related substances in Carvedilol under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity profiling.
• Research & Development: Utilized in synthetic chemistry research to study the metabolism and degradation pathways of Carvedilol.

Basic Information

Product Name	n-Methyl Carvedilol (Carvedilol Impurity)
CAS No.	72956-35-5
Molecular Formula	C25H28N2O4
Molecular Weight	420.50 g/mol
Synonyms	1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]methylamino]-2-propanol; N-Methyl Carvedilol; Carvedilol N-Methyl Analog; Carvedilol Impurity F; Carvedilol Related Compound F; (±)-1-(Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]methylamino]-2-propanol; UNII-1Q6KQ8F2C6
EINECS	Contact for details

Quality Control

Our n-Methyl Carvedilol is manufactured and handled 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 impurity analysis. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary reference standards where applicable. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants and inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
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 ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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