Description

Carvedilol Impurity Dba is a high-purity reference standard used in the pharmaceutical development and quality control of the cardiovascular drug Carvedilol. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, manufacturing, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Carvedilol and its related substances.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities in Carvedilol active pharmaceutical ingredient (API) and finished dosage forms.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure Carvedilol batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to identify and track degradation products that may form in Carvedilol formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity profiling.
• Research and Development: Supports synthetic route development and process optimization by helping to identify and eliminate process-related impurities.

Basic Information

Item	Detail
Product Name	Carvedilol Impurity Dba
CAS No.	3258-70-6
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 D; Carvedilol Related Compound D; BM 14190 Impurity; (RS)-1-(Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol; 4-[2-Hydroxy-3-[[2-(2-methoxyphenoxy)ethyl]amino]propoxy]-9H-carbazole
EINECS	Contact for details

Quality Control

Every batch of Carvedilol Impurity Dba is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against predefined specifications. Our quality commitment supports compliance with ICH Q3A/B guidelines and other relevant regulatory frameworks for pharmaceutical impurities.

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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

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 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.