Description

Carvedilol Impurity 12 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities in Carvedilol, a widely prescribed β-blocker medication. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing. Ensuring the integrity of this impurity standard is fundamental to maintaining drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Impurity Profiling: Identification and quantification of this specific impurity in Carvedilol Active Pharmaceutical Ingredient (API) batches.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure Carvedilol drug substances and products meet stringent purity specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Monitoring the formation of this impurity over time under various stress conditions to establish drug shelf-life.
• Process Chemistry Research: Aiding chemists in optimizing synthesis pathways to minimize the formation of this specific by-product.

Basic Information

Product Name	Carvedilol Impurity 12
CAS No.	1059573-45-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carvedilol Related Compound 12; Carvedilol EP Impurity J; Carvedilol USP Impurity; 1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol Impurity; Carvedilol Process Impurity; Carvedilol Degradant; (RS)-1-(Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol Related Substance
EINECS	Contact for details

Quality Control

Every batch of Carvedilol Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A/B guidelines and requirements from the USP, EP, and CP.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
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)	≤ 1.0% w/w

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