Description

Metoprolol Ep Impurity M is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Metoprolol, a widely prescribed β-blocker medication. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining the stringent purity standards required in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Metoprolol active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays in pharmaceutical manufacturing.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies of Metoprolol to understand degradation pathways and establish shelf-life.
• Research & Development: Used in pharmaceutical R&D for studying the metabolism, synthesis pathways, and impurity formation mechanisms of Metoprolol.

Basic Information

Item	Detail
Product Name	Metoprolol Ep Impurity M
CAS No.	343785-33-1
Molecular Formula	C15H25NO3
Molecular Weight	267.36 g/mol
Synonyms	1-(Isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol Impurity M; Metoprolol Related Compound M; Metoprolol EP Impurity M; Metoprolol Impurity 7; Metoprolol Process Impurity; 2-Propanol, 1-(isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]-, (RS)-; (RS)-Metoprolol Impurity M
EINECS	Contact for details

Quality Control

Every batch of Metoprolol Ep Impurity M is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents in accordance with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 product 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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