Meaning of pharmaceutical
API(active pharmaceutical ingredients) refer to the raw material components used to produce various preparations.
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Generally speaking, the development and production of an API include laboratory research, small-scale trial production, pilot production and industrial production.
1. During the laboratory research stage, all separation and purification methods such as fractionation, recrystallization, and various chromatography techniques are used to prepare a small amount of samples for pharmacological screening. Such synthesis methods are still far from industrial production. The laboratory research stage is relatively important in the chemical drug research and development process. The main tasks of this stage are:
(1) Understand whether there are intellectual property issues in the synthesis route and whether the production cost is acceptable.
(2) Rationally design the compound to complete the synthesis of the compound as soon as possible.
(3) Take various measures to confirm the chemical structure of the compound.
(4) Determine the main physical parameters of the compound.
(5) Understand the general properties of the compound.
2. Secondly, the original laboratory synthesis routes and methods are comprehensively and systematically reformed. Through laboratory batch synthesis and data accumulation, a synthetic process route that is basically suitable for pilot production is determined.
3. During the pilot stage, it is necessary to clarify whether the industrial-grade raw materials and solvents interfere with the reaction and whether they affect the yield and quality of the product. Through small-scale research, we can find out the best reaction conditions and treatment methods suitable for production with industrial-grade raw materials, so as to achieve the goals of low price, high quality and high yield. The industrial production of APIs has two important applications. One is for the production of corresponding preparations, and the other is for domestic and foreign sales in the form of APIs and chemical raw materials. It transforms the process from laboratory theory to production and converts samples into products.
