What are the key considerations for Catalysis under ICH Q11?
Several important considerations must be taken into account when dealing with catalysis under ICH Q11:
Catalyst Selection: The choice of catalyst can significantly impact the efficiency and specificity of the reaction. It's crucial to select a catalyst that maximizes yield while minimizing by-products. Process Optimization: Optimizing reaction conditions such as temperature, pressure, and pH to enhance catalytic activity and selectivity. Characterization of Catalysts: Understanding the physical and chemical properties of the catalyst to ensure it functions as intended. Control Strategy: Establishing a robust control strategy to monitor and maintain catalytic performance throughout the manufacturing process.
