Description

Carvedilol Related Compound A is a high-purity reference standard and pharmaceutical intermediate critical for quality control and research in the development of Carvedilol, a widely used β-blocker. This compound serves as a key impurity marker, essential for ensuring the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on cardiovascular drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Carvedilol API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods in QC laboratories.
• Pharmaceutical Research & Development: Employed in stability studies, degradation pathway analysis, and process chemistry research for Carvedilol.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiles and specifications.
• Quality Control Testing: Essential for routine batch release testing of Carvedilol to ensure it meets pharmacopeial standards (USP, EP, BP).
• Academic & Clinical Research: Used in universities and research hospitals for studies related to β-blocker metabolism and pharmacology.

Basic Information

Product Name	Carvedilol Related Compound A
CAS No.	1076199-79-5
Molecular Formula	C24H26N2O4
Molecular Weight	406.48 g/mol
Synonyms	1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol; Carvedilol Impurity A; Carvedilol EP Impurity A; Carvedilol USP Related Compound A; 4-[[2-Hydroxy-3-[[2-(2-methoxyphenoxy)ethyl]amino]propoxy]-9H-carbazole; UNII-6C6W9GBA0B
EINECS	Contact for details

Quality Control

Our Carvedilol Related Compound A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substances profiling, and identity confirmation (IR, MS) to ensure compliance with pharmacopeial standards (USP, EP). A detailed Certificate of Analysis (COA) is provided with every shipment, guaranteeing traceability and consistency for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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