There are usually multiple synthetic routes for any compound, and the same is true for drug synthesis. For the synthesis of APIs, the ultimate goal is to enter the factory mass production, so it is very important to choose a suitable route for their own production. This paper mainly discusses the selection of synthetic routes, and puts forward some immature views for your reference.
Determination of starting materials
In the synthesis process of an API, the selection of starting materials is the key. It also determines whether the starting time of R & D and the cost of raw materials are appropriate.
Firstly, the process route can be determined by selecting the starting material;
Secondly, through the selection of starting materials, the basic workload and R & D cycle can be determined;
Thirdly, the selection of starting materials determines the difficulty in the registration process;
Fourth, through the selection of starting materials, the most important thing is to determine the basic cost of a product, thus laying a competitive position in the market.
There are many preparation routes for both new drugs and generic drugs. Whether the complete process route or the final process route determined through the independent unit reaction screening are all from the information provided by the literature and other channels. All possible routes should be listed, and several more suitable routes (preferably 2-3 routes) should be selected theoretically, and then a better reaction route or combination of a better reaction route should be selected or combined based on the actual operation of the route 。