Description

Gadobenate Dimeglumine is a paramagnetic ionic contrast agent, a gadolinium-based complex specifically designed for diagnostic imaging. Its primary value lies in its dual hepatobiliary and renal excretion pathway, making it a versatile agent for magnetic resonance imaging (MRI). This product is essential for pharmaceutical manufacturers, research institutions, and diagnostic centers developing and producing advanced contrast media for enhanced visualization of the liver, central nervous system, and vascular structures.

Application

• MRI Contrast Media: Primary active pharmaceutical ingredient (API) in formulations for magnetic resonance imaging.
• Hepatobiliary Imaging: Used in liver-specific MRI scans to detect and characterize focal liver lesions due to its partial hepatobiliary excretion.
• Central Nervous System (CNS) Imaging: Enhances contrast for MRI of the brain and spine to improve detection of tumors, inflammation, and vascular abnormalities.
• Angiography (MRA): Employed in magnetic resonance angiography for non-invasive visualization of blood vessels.
• Pharmaceutical R&D: Serves as a key reference standard and intermediate in the research and development of novel diagnostic agents.
• Clinical Diagnostics: Formulated into finished injectable solutions used in hospital and clinical radiology departments worldwide.

Basic Information

Product Name	Gadobenate Dimeglumine
CAS No.	12700-20-8
Molecular Formula	C28H38GdN5O11 • 2C7H17NO5
Molecular Weight	1058.18 g/mol (as dimeglumine salt)
Synonyms	Gadobenate Dimeglumine; Gd-BOPTA; Gadobenate Dimeglumine Salt; MultiHance (Brand Name); Gadolinium Benzyloxypropionic Tetraacetate Dimeglumine; (4S)-4-(4-Ethoxybenzyl)-3,6,9-tris(carboxylatomethyl)-3,6,9-triazaundecanedioic acid; Gadolinium(3+) ion compd. with N-methyl-D-glucamine (1:2); BOPTA dimeglumine gadolinium salt
EINECS	Contact for details

Quality Control

Our Gadobenate Dimeglumine is manufactured and tested under strict quality systems to meet the rigorous standards required for pharmaceutical APIs. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) confirming identity, purity, and compliance with relevant specifications. We support development and commercial projects requiring material that aligns with ICH guidelines and current Good Manufacturing Practice (GMP) standards.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 10 ppm
Free Gadolinium	≤ 0.01%
Free Dimeglumine	≤ 0.5%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Bacterial Endotoxins	< 10 EU/mg (for injectable grade)
Sterility	Sterile (for finished API grade, as per test requirement)

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