Description

Gadoxetate Disodium is a paramagnetic contrast agent specifically designed for magnetic resonance imaging (MRI). Its primary value lies in its hepatobiliary excretion, making it a critical diagnostic tool for the detailed visualization of liver tissue and function. This compound is essential for pharmaceutical manufacturers and research institutions developing and producing advanced diagnostic imaging agents. The product is supplied as a high-purity active pharmaceutical ingredient (API) to meet stringent pharmacopeial standards.

Application

• Primary Pharmaceutical Ingredient: Used as the active pharmaceutical ingredient (API) in the formulation of injectable MRI contrast agents.
• Liver-Specific MRI: Enables enhanced detection and characterization of focal liver lesions, including hepatocellular carcinoma (HCC), metastases, and benign tumors.
• Hepatobiliary Function Assessment: Facilitates the evaluation of liver function and biliary anatomy by being taken up by functioning hepatocytes and excreted into the bile.
• Research & Development: Serves as a key reference standard and starting material in pharmaceutical R&D for novel diagnostic imaging compounds.
• Clinical Diagnostics: Integral to advanced diagnostic protocols for pre-surgical planning and monitoring of liver disease progression or treatment response.

Basic Information

Product Name	Gadoxetate Disodium
CAS No.	135326-22-6
Molecular Formula	C23H28GdN3Na2O11
Molecular Weight	725.66 g/mol
Synonyms	Gadolinium-EOB-DTPA; Gd-EOB-DTPA; Gadoxetic Acid Disodium Salt; EOB-GD-DTPA; Primovist (Brand Name); Eovist (Brand Name); (4S)-4-(4-Ethoxybenzyl)-3,6,9-tris(carboxylatomethyl)-3,6,9-triazaundecanedioic Acid, Gadolinium Complex, Disodium Salt
EINECS	Contact for details

Quality Control

Our Gadoxetate Disodium is manufactured under strict quality management systems. Each batch is tested to ensure compliance with high-purity pharmacopeial standards (e.g., USP, Ph. Eur.) for use as an API. Comprehensive testing includes identification, assay, impurity profiling, residual solvents, and heavy metal analysis. A Certificate of Analysis (COA) documenting all release specifications is provided with every 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). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

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% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0 %
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 0.5 EU/mg
pH (1% Solution)	6.5 - 8.0

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