Abstract

To overcome the unmet needs of patients, the production of active pharmaceutical ingredients (APIs) with limited lead timelines has become critical. Along with timelines to secure robust, economical and greener processes, the utilization of metal catalysts (palladium, rhodium and ruthenium catalysts) has become vital in the pharmaceutical industry. The presence of metal impurities in APIs can pose significant risks to human health and compromise the quality of pharmaceutical products. According to the ICH Q3D guideline, the permitted daily exposure (PDE) for metals in APIs is established based on toxicological data and the PDE values are expressed in micrograms per day and vary for different metals [1,2]. It is important to note that the acceptable limits for metal impurities can vary depending on factors such as the route of administration, patient population, and potential toxicity of the metal. In general, the metal impurities in APIs must be controlled to low levels (<10μg/g) [3]. Therefore, it is crucial to develop effective purification methods to reduce metal content in APIs. Resins have emerged as valuable tools in the pharmaceutical industry for the selective removal of metal impurities. This review provides an overview of the use of resins for the reduction of metals in APIs..