Chemistry
Synthetic Route Discovery
Active pharmaceutical ingredient (API) process development involves optimizing the manufacturing process for the active ingredient in a drug. In order to optimize processes, new production methods must be devised or existing processes are refined. This process involves many steps, such as creating synthetic routes, optimizing reaction conditions, and choosing appropriate solvents and reagents. The ultimate goal is to develop a synthetic route that is efficient and cost-effective with sustainable processes as the scale of manufacturing goes up. The following methods are used to accomplish this goal:
- Minimizing the number of steps
- Maximizing yields
- Ensuring starting material availability / minimize cost
- Eliminating/minimizing silica gel chromatography
- Avoiding very low-temperature reactions
- Eliminating highly hazardous reagents and reaction conditions
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