Description

Gadoxetate Disodium Impurity 10 is a specified impurity of the magnetic resonance imaging (MRI) contrast agent Gadoxetate Disodium. This compound is critical for pharmaceutical research and development, serving as a reference standard for quality control and regulatory compliance. It is primarily required by manufacturers and analytical laboratories involved in the synthesis, purification, and batch release testing of the active pharmaceutical ingredient (API). Ensuring the availability of high-purity impurity standards is essential for maintaining drug safety and efficacy.

Application

• As a Pharmaceutical Reference Standard for the identification and quantification of impurities in Gadoxetate Disodium API.
• For Method Development and Validation in analytical laboratories using HPLC, LC-MS, or other chromatographic techniques.
• In Stability Studies to monitor degradation pathways and establish shelf-life for the final drug product.
• For Regulatory Submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Used in Research and Development to understand the chemical behavior and synthesis pathways of gadolinium-based contrast agents.
• As a Quality Control (QC) Tool in manufacturing facilities for in-process testing and final batch release.

Basic Information

Product Name	Gadoxetate Disodium Impurity 10
CAS No.	158703-75-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gadoxetate Disodium Related Compound; Gadoxetate Impurity 10; EOB-DTPA Impurity; Gd-EOB-DTPA Impurity 10; Gadolinium Ethoxybenzyl DTPA Impurity; 158703-75-4; (4S)-4-(4-Ethoxybenzyl)-3,6,9-tris(carboxylatomethyl)-3,6,9-triazaundecanedioate gadolinium salt impurity
EINECS	Contact for details

Quality Control

Our Gadoxetate Disodium Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, NMR, and mass spectrometry. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is moisture-sensitive (hygroscopic) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 2.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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