Abstract：OBJECTIVE To discuss basic strategies for impurity control of apixaban combining with the relevant literatures, patents, and ICH M7 guidelines, in order to give some advices on the comprehensive research of impurities of generic drugs of apixaban. METHODS Apixaban and apixaban tablets are hot points in application of generic drugs in recent years.The research of genotoxic impurities involved in the synthesis of apixaban is the key point in generics research. In the article, the analysis and control of potential impurities were discussed, focusing on the control of the genotoxic impurities. RESULTS AND CONCLUSION The analysis and control of apixaban′s potential genotoxic impurities were discussed based on the synthetic route, material characteristics of apixaban and ICH M7 guidelines. The control of genotoxic impurities is one of the important contents of the quality control of apixaba. A scientific control strategy should be established in conjunction with the removal and tracking research of the impurities.
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