Description

Metoprolol Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the cardiovascular drug Metoprolol by serving as a key marker in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments focused on compliance and product development.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Metoprolol drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate comprehensive control strategies.
• Stability Studies: Used to track the formation of degradation products in Metoprolol formulations under various stress conditions.
• Chemical Research: Acts as a building block or intermediate for researchers studying the metabolism, synthesis pathways, or structural activity relationships of β-blockers.

Basic Information

Product Name	Metoprolol Impurity 4
CAS No.	287944-27-8
Molecular Formula	C15H25NO3
Molecular Weight	267.37 g/mol
Synonyms	1-[4-(2-Methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]-2-propanol impurity; Metoprolol Related Compound; Metoprolol EP Impurity; Metoprolol USP Impurity; 2-Propanol, 1-[4-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]-; O-Desmethyl Metoprolol Impurity; Metoprolol Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Metoprolol Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial standards (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.