Description

Metoprolol Impurity 14 is a specified impurity and degradation product of the widely used β-blocker, Metoprolol. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control testing. It is essential for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry who require high-purity materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Metoprolol active pharmaceutical ingredient (API) and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) to meet ICH Q3A/B guidelines.
• Used in stability studies to monitor degradation pathways and establish shelf-life for Metoprolol-based drug products.
• Essential for pharmaceutical quality control (QC) laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP, JP).
• Supports regulatory submissions (e.g., ANDA, NDA) by providing impurity profiling data.
• Valuable for academic and contract research organizations (CROs) conducting pharmacokinetic and metabolic studies.

Basic Information

Product Name	Metoprolol Impurity 14
CAS No.	29121-23-1
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 D; Metoprolol USP Impurity; 2-Propanol, 1-[4-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]-; O-Desmethyl Metoprolol; Desmethyl Metoprolol; Metoprolol Metabolite
EINECS	Contact for details

Quality Control

Our Metoprolol Impurity 14 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure the highest standards of purity and identity. Each batch is characterized using advanced techniques including HPLC, GC, NMR, and Mass Spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile, ensuring compliance with pharmacopeial and ICH guidelines for reference standards.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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