Description

Metoprolol Impurity 9 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 the cardiovascular drug Metoprolol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Metoprolol drug substances and finished products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing data for impurity identification and qualification as per ICH guidelines.
• Stability Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability testing of Metoprolol formulations.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Metoprolol under various conditions.
• Quality Control Testing: Serves as a system suitability standard and for routine batch release testing to ensure impurity levels are within specified limits.

Basic Information

Product Name	Metoprolol Impurity 9
CAS No.	1155083-53-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Metoprolol Related Compound 9; Metoprolol EP Impurity J; Metoprolol USP Impurity; Metoprolol Degradation Product; 1-(Isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol Impurity; (RS)-1-(Isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol Related Substance; Metoprolol Process Impurity
EINECS	Contact for details

Quality Control

Our Metoprolol Impurity 9 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS) and purity determination by HPLC to ensure it meets the stringent requirements for a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability are provided and 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. 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 matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.