Compared with pharmaceutical preparations, the production process of API has its own characteristics. The production of API often involves complex chemical and biological processes, with complex intermediate control processes. Its production process often produces by-products, so purification processes are usually required. Different kinds of production equipment differ greatly from the operation process, and the same reaction equipment is usually used for different reactions.
With the development of science and technology, automatic production facilities equipment and on-line monitoring system are increasingly used in the production of API, but due to cognitive constraints, the mechanism of some chemical and biological reactions has not been thoroughly understood.
The process of API is complex and diverse, and some processes are very long. Generally speaking, there is a refining process in the production process of API, the main purpose of this process is to remove impurities in API. In the process of preparation production, there are few changes in the chemical structure of the material, but in the process of raw material production, the change of the chemical structure of the material is frequent.