Identification, Synthesis, Characterization, and Control Strategy Establishment for Process Impurities of Baloxavir Marboxil
Huixiong Lu,
Guobin Xu,
Jingping Kou
et al.
Abstract:This manuscript provides a comprehensive summary of 12 process impurities in baloxavir marboxil, including four previously unreported impurities. Through identification, synthesis, and characterization using MS and NMR techniques, the formation pathways of each impurity were proposed to enhance the understanding of the process. Corresponding control strategies were established. Three batches of kilogram-scale demonstrations were conducted, resulting in baloxavir marboxil with a yield of 51%, purity exceeding 9… Show more
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