Description

Gadolinium Dota Meglumine is a paramagnetic macrocyclic complex, widely recognized as a key active pharmaceutical ingredient (API) in contrast agents for magnetic resonance imaging (MRI). This compound is specifically engineered for its exceptional thermodynamic and kinetic stability, which is critical for patient safety and diagnostic efficacy. It is an essential component for pharmaceutical manufacturers and diagnostic imaging centers requiring high-purity, reliable contrast media to enhance vascular and soft tissue visualization.

Application

• MRI Contrast Media: Primary active ingredient in gadolinium-based contrast agents (GBCAs) for diagnostic magnetic resonance imaging.
• Angiography: Used in MR angiography (MRA) to obtain clear images of blood vessels and assess vascular diseases.
• Neurological Imaging: Enhances the detection and characterization of brain tumors, inflammation, and lesions in the central nervous system.
• Body Imaging: Improves contrast for liver, breast, and musculoskeletal system scans, aiding in tumor detection and staging.
• Pharmaceutical Research: Serves as a reference standard and key intermediate in the R&D of new diagnostic agents.
• Radiopharmaceuticals: Potential precursor or model compound in the development of other metal-chelate based imaging agents.

Basic Information

Product Name	Gadolinium Dota Meglumine
CAS No.	92943-93-6
Molecular Formula	C28H54GdN5O10
Molecular Weight	753.12 g/mol
Synonyms	Gadoterate Meglumine; Gadolinium(III) 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetate Meglumine Salt; Gd-DOTA Meglumine; Dotarem® (Brand Name); Gadoterate Meglumine Salt; Gadolinium Tetraazacyclododecanetetraacetic Acid Meglumine; Meglumine Gadoterate; Gadoterate N-Methylglucamine Salt
EINECS	Contact for details

Quality Control

Our Gadolinium Dota Meglumine is manufactured under strict quality management systems, targeting compliance with Pharmaceutical (Ph. Eur., USP) standards. Each batch undergoes rigorous analytical testing, including assay, impurity profiling, and residual solvent analysis, to ensure it meets the stringent requirements for injectable APIs. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing all critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0% (anhydrous basis)
pH (1% solution)	6.5 - 7.5
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Free Gadolinium	≤ 0.1%
Free DOTA Ligand	≤ 0.5%
Bacterial Endotoxins	< 1.0 EU/mg
Sterility (if applicable)	Sterile or suitable for aseptic processing

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