Selective nitration in a microreactor for pharmaceutical production under cGMP conditions

DSM as manufacturer of fine chemicals and active pharmaceutical ingredients and Corning Incorporated as manufacturer of modular micro-structured flow-through reactors have collaborated to develop and pilot a new process to perform a selective nitration under cGMP conditions. Nitration reactions are difficult to handle due to the exothermic properties of organic nitrates. In order to achieve high selectivity, classically high dilution conditions are used. DSM developed and intensified a process to utilize the capabilities of the Corning's reactor technology, combining the advantages of the micro-structured devices with extraction equipment. This combination has resulted in a highly efficient process, which was quickly and easily transferred from the laboratory to production, resulting in the processing of more than 25 metric tons of material and in the production of more than 0.5 metric tons of the desired quality product under cGMP conditions.