Impurities analysis and control strategies of gadobutrol contrast agents
DONG Chen-huan
WANG Gang
HE Yan
Abstract：Gadobutrol and its injections are the most widely used Gd(III)-based contrast agents in recent years.Combined with the synthesis route of drug substance,the organic impurities and inorganic impurities were analyzed,including starting materials,intermediates,by-products,degradation products,residual solvents,elemental impurities and chiral impurities.Based on the idea of"quality by design",this paper proposes impurities control measures to achieve pharmaceutical product lifecycle management,ensuring the safety,effectiveness and quality controllability of drugs.
Keywords：gadobutrolGd(III)-based contrast agentsimpurities analysiscontrol strategy
Publication Date：2024-12-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2456-2461 )