Synthesis,Characterization and Detection of Potential Genotoxic Impurity of Onradivir
This article aims to study the potential genotoxic impurities of the new class I influenza drug,Onradivir.3-Azide-5-fluoro-1-(tetrahydro-2H-pyrano-2-yl)-1H-pyrazole[3,4-b]pyridine(SMI-H),which is a potentially genotoxic impurity in the Onradivir,was synthesized with 2-chloro-5-fluoronicotinonitrile as the starting material.The structure of the target compound was identified by 1H NMR,13C NMR and MS(ESI).The content detection was established by LC-MS method and the results showed that it was not detected in the Onradivir,but in the SMI(0.1％～0.2％).The impurity content was lower than the standard limitation(≤0.3％).So the safety risk was controllable in the Onradivir.
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