Description

Carvedilol Impurity 3 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Carvedilol. This compound is critical for ensuring the purity, safety, and efficacy of Carvedilol-based drug formulations by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Carvedilol Impurity 3 in Carvedilol API and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating stability-indicating HPLC or UPLC methods for Carvedilol.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure API batches meet International Conference on Harmonisation (ICH) guidelines and pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Process Chemistry & Optimization: Helps chemists identify and mitigate the source of this impurity during the synthesis and purification stages of Carvedilol manufacturing.

Basic Information

Item	Detail
Product Name	Carvedilol Impurity 3
CAS No.	1187921-93-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carvedilol Related Compound 3; Carvedilol EP Impurity C; Carvedilol USP Impurity; 1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol Impurity; 1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol Related Substance; (±)-1-(Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol Impurity; Carvedilol Process Impurity; Carvedilol Degradant
EINECS	Contact for details

Quality Control

Every batch of Carvedilol Impurity 3 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization and purity verification using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure it meets the exacting standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on identity, purity, and impurities. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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