Description

Metoprolol Impurity 1 is a high-purity chemical reference standard used in the analysis and quality control of the cardiovascular drug Metoprolol. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a certified reference material for impurity profiling in active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Metoprolol tartrate and succinate APIs and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing, calibrating, and validating chromatographic methods for quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in Metoprolol under various stress conditions (e.g., heat, light, humidity).
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (USP, EP, BP) that specify impurity limits for Metoprolol.
• Academic & Contract Research: Used in academic research and by CROs (Contract Research Organizations) for studies related to drug metabolism, pharmacokinetics, and impurity synthesis pathways.

Basic Information

Product Name	Metoprolol Impurity 1
CAS No.	150332-88-0
Molecular Formula	C15H25NO3
Molecular Weight	267.36 g/mol
Synonyms	1-(Isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol; Metoprolol Related Compound A; Metoprolol EP Impurity A; Metoprolol USP Related Compound A; 2-Propanol, 1-(isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]-; (RS)-1-(Isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol; Metoprolol Impurity A
EINECS	Contact for details

Quality Control

Every batch of Metoprolol Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopoeial and in-house specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.