Description

Metaraminol Bitartrate Impurity 5 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the active pharmaceutical ingredient Metaraminol Bitartrate. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is primarily utilized by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and biotechnology industries for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying this specific impurity in Metaraminol Bitartrate drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure drug substance and product batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity understanding and control strategies.
• Research on Synthetic Pathways and Process Chemistry: Aids chemists in understanding and optimizing the synthesis of Metaraminol Bitartrate to minimize impurity formation.

Basic Information

Product Name	Metaraminol Bitartrate Impurity 5
CAS No.	2734404-77-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Metaraminol Related Compound 5; Metaraminol Bitartrate Related Substance 5; Metaraminol Impurity F; Metaraminol EP Impurity F; Metaraminol USP Impurity; 1-(3-Hydroxyphenyl)-2-(methylamino)ethanol Bitartrate Impurity 5; Aramine Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Metaraminol Bitartrate Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA), detailing results from tests such as HPLC purity, related substances, and spectroscopic identification, is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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