Description

Metaraminol Bitartrate Impurity 4 is a specified impurity of the active pharmaceutical ingredient Metaraminol Bitartrate, a sympathomimetic amine used as a vasopressor. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Metaraminol Bitartrate drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Primary use as a Pharmaceutical Reference Standard for the identification and quantification of impurities in Metaraminol Bitartrate API.
• Critical component in Analytical Method Development and Validation (e.g., HPLC, UPLC) for impurity profiling.
• Essential for Stability Studies and forced degradation studies to understand impurity formation pathways.
• Used in Quality Control (QC) Laboratories for routine batch release testing of Metaraminol Bitartrate.
• Serves as a Regulatory Compliance Tool to meet ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Valuable for Research and Development of synthetic routes and purification processes for the parent API.

Basic Information

Product Name	Metaraminol Bitartrate Impurity 4
CAS No.	19289-78-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Metaraminol Related Compound; Metaraminol Bitartrate Specified Impurity; Metaraminol Impurity D; 1-(3-Hydroxyphenyl)-2-methylaminoethanol Bitartrate Impurity; Metaraminol Tartrate Impurity; Aramine Impurity; (-)-Metaraminol Impurity; (R)-Metaraminol Bitartrate Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Metaraminol Bitartrate Impurity 4 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification, aligning with current industry and regulatory expectations for reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

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 degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.