Utilization of synthetic chemistry routes developed in late lead optimization is becoming more widespread as the desire to efficiently confirm pre-clinical compounds has increased. In some cases, chemical processes use reagents which are specific and cannot be substituted on scale up. Such reagents include transition metal catalysts.
These catalytic reactions using precious metals such as Pd, Pt, Ru and Rh, are becoming more popular in industrial synthesis due to atom economy and greener environmental credentials. However, limits for residual impurities or metal in final products/APIs, by FDA and EMEA (ICH Guidelines Q3D Step 5 version issued on 16.12.2014) are becoming increasingly challenging to meet.
Classical methods to remove these metals such as recrystallization, distillation or extraction are energy intensive or may be irreproducible. The use of carbon adsorption methods for example is also quite widespread but can have varying results, including significant loss of API.
Literature number: P166
Published: Dec 6, 2025 11:11:34 PM
