Description

Disodium:2-[Bis[2-[Bis(Carboxylatomethyl)Amino]Ethyl]Amino]Acetate:Gadolinium(3+) is a gadolinium-based macrocyclic complex, specifically designed as a highly stable contrast agent for magnetic resonance imaging (MRI). Its core value proposition lies in its exceptional thermodynamic and kinetic stability, which is critical for patient safety and diagnostic reliability in clinical settings. This product is essential for manufacturers and formulators in the pharmaceutical and medical diagnostics industries who require a reliable, high-purity active pharmaceutical ingredient (API) for advanced imaging applications.

Application

• Primary active ingredient in gadolinium-based MRI contrast agents for enhanced visualization of blood vessels, organs, and tissues.
• Used in the formulation of contrast media for neurological imaging, including brain and spinal cord scans.
• Critical component for cardiovascular MRI procedures to assess heart function and vascular structures.
• Base material for oncology imaging agents to improve tumor detection and characterization.
• Key intermediate in pharmaceutical research and development for next-generation diagnostic agents.
• Used in preclinical and clinical studies requiring high-stability gadolinium chelates.

Basic Information

Product Name	Disodium:2-[Bis[2-[Bis(Carboxylatomethyl)Amino]Ethyl]Amino]Acetate:Gadolinium(3+)
CAS No.	92923-64-3
Molecular Formula	C16H23GdN4Na2O10
Molecular Weight	661.62 g/mol
Synonyms	Gadolinium(III) DOTA; Gadoterate Meglumine (Salt Form); Gadoterate Disodium; DOTA-Gd; Gadoterate; Dotarem® (Brand Name); 1,4,7,10-Tetraazacyclododecane-1,4,7,10-tetraacetic acid, gadolinium complex; Gd-DOTA
EINECS	Contact for details

Quality Control

Our Disodium:2-[Bis[2-[Bis(Carboxylatomethyl)Amino]Ethyl]Amino]Acetate:Gadolinium(3+) is manufactured under strict quality systems suitable for pharmaceutical applications. Production adheres to current Good Manufacturing Practices (cGMP) and is supported by a comprehensive quality management system. Every batch is subjected to rigorous analytical testing, including HPLC for purity and assay, ICP-MS for elemental impurities, and tests for residual solvents and endotoxins. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring full traceability and compliance with ICH Q3 and relevant pharmacopeial standards (e.g., USP, Ph. Eur.).

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature of 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0% (anhydrous basis)
Free Gadolinium	≤ 0.1%
Free Ligand (DOTA)	≤ 0.5%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Heavy Metals (ICP-MS)	≤ 20 ppm
Endotoxins (LAL)	≤ 1.0 EU/mg
pH (1% Solution)	6.5 - 7.5

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