Description

Metaraminol Bitartrate Impurity 1 is a designated 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 analytical method development and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Metaraminol Bitartrate drug substances and products.

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 (HPLC, GC, LC-MS) for impurity profiling.
• Essential for Quality Control and Assurance laboratories to monitor and control impurity levels during API synthesis.
• Used in Stability Studies to track the formation of degradation products over time.
• Serves as a Research Chemical for studying the metabolism and degradation pathways of Metaraminol.
• Supports Regulatory Submissions (e.g., for FDA, EMA) by providing characterized impurity data.

Basic Information

Product Name	Metaraminol Bitartrate Impurity 1
CAS No.	639070-81-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Metaraminol Related Compound; Metaraminol Impurity A; Metaraminol Bitartrate EP Impurity; 1-(3-Hydroxyphenyl)-2-methylaminoethanol Bitartrate Impurity; Aramine Impurity; (-)-Metaraminol Impurity; Pressorol Impurity; Metaraminol Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Metaraminol Bitartrate Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and chromatographic data is provided with each shipment.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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%
Assay	Contact for details
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	Contact for details

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