Development of a Control Strategy for Hydrogenation of Aryl Nitro Analogs by Kinetic Justification

This
article describes the development of a control strategy for
controlling potentially mutagenic impurities that result from the
hydrogenation of aryl nitro analogs, utilizing concepts outlined in
the International Conference on Harmonisation guidelines (ICH M7,
Option 4). A kinetic model was developed in conjunction with a detailed
understanding of gas–liquid mixing principles and heterogeneous
catalyst properties to provide a process for commercial manufacturing
control included in the manufacturing of pibrentasvir.