Description

Gadobutrol is a gadolinium-based macrocyclic contrast agent used in magnetic resonance imaging (MRI). Its primary value lies in its high thermodynamic and kinetic stability, which is critical for patient safety and diagnostic efficacy. This product is essential for pharmaceutical manufacturers, diagnostic imaging centers, and research institutions developing or utilizing advanced contrast-enhanced MRI procedures.

Application

• As the active pharmaceutical ingredient (API) in contrast media for diagnostic magnetic resonance imaging (MRI).
• Enhancement of cerebral and spinal lesions in neurological MRI scans.
• Improving visualization of vascular structures in magnetic resonance angiography (MRA).
• Used in the detection and characterization of breast tumors via contrast-enhanced breast MRI.
• Research and development of novel diagnostic imaging formulations and protocols.
• Manufacturing of finished, sterile injectable pharmaceutical products under GMP conditions.

Basic Information

Product Name	Gadobutrol
CAS No.	138071-82-6
Molecular Formula	C18H31GdN4O9
Molecular Weight	604.72 g/mol
Synonyms	Gadobutrolum; Gadovist (trade name); Gadavist (trade name); 10-[2,3-Dihydroxy-1-(hydroxymethyl)propyl]-1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid gadolinium complex; Gd-BT-DO3A; Gadolinium-1,4,7-tris(carboxymethyl)-10-(2,3-dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclododecane; Gadolinium chelate with 10-(2,3-dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid
EINECS	Contact for details

Quality Control

Our Gadobutrol is manufactured and tested to meet the stringent requirements of pharmacopeial standards, including Ph. Eur. and USP, where applicable. Every batch undergoes rigorous analytical testing to ensure identity, purity, potency, and the absence of critical impurities such as free gadolinium. A comprehensive Certificate of Analysis (COA) documenting all release specifications is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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.

Specification

Item	Specification
Appearance	White to almost white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0 %
Residue on Ignition	≤ 0.1 %
Heavy Metals	≤ 20 ppm
Free Gadolinium	≤ 0.1 %
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Bacterial Endotoxins	< 0.5 EU/mg

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