The process amplification of API refers to the enlargement of the production of API from laboratory scale to industrial scale, which is the only way from research and development to production of pharmaceutical preparations . Process scale-up is an indispensable development process for APIs to adopt large-scale production and realize industrialization. Its purpose is to verify, review, and improve the reaction conditions determined by the laboratory process, and to study the structure, material, and material of the selected industrial production equipment. Installation and workshop layout, etc., can provide data, materials and consumption for formal production, and are effective measures to reduce industrialization risks. Today, let’s take a brief look at the process of API process amplification and the problems that may arise in the process of API process amplification. The process of bulk drug process amplification Step1: In pharmaceutical product dev...
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