Description

Metaraminol Bitartrate Impurity 3 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 reference standard for analytical method development, validation, and quality control. 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

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Metaraminol Bitartrate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Critical for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control.
• Research & Synthesis: Serves as a key intermediate or marker in synthetic chemistry research and process development for related compounds.

Basic Information

Product Name	Metaraminol Bitartrate Impurity 3
CAS No.	21480-43-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(3-Hydroxyphenyl)-2-methylaminoethanol Bitartrate Impurity 3; Metaraminol Related Compound C; Metaraminol Tartrate Impurity 3; Metaraminol Bitartrate EP Impurity C; Aramine Impurity 3; (R*,S*)-α-(1-Aminoethyl)-3-hydroxybenzyl alcohol hydrogen tartrate impurity; Pressorol Impurity
EINECS	Contact for details

Quality Control

Our Metaraminol Bitartrate Impurity 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results. Our quality assurance protocols are designed to support compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment. For long-term storage, consider conditions recommended for hygroscopic and light-sensitive compounds.

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%

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