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If we want to improve the product quality of API pharma, we must focus on selecting the appropriate process design and implementing the specific steps. For chemical API medicines discussed in this article, the most important factors are to choose the right chemical reactions and another critical separation purification method.
With the advancement of technology and the development of the manufacturing industry, organic synthetic chemistry has reached a relatively high level. Almost all structural molecules can be prepared through various reactions. We should not view whether the reactions are feasible as a challenge, but the fundamental problem in process design is how to choose the right reaction. Making complex separation and purification methods simple can be an excellent strategy to tackle this selection problem.
The preparation of chemical API pharma begins with relatively impure commercial starting materials and reagents. In general, the starting materials and reagents used in the production process should have a clear molecular formula, chemical structure and name, with the physical and chemical properties and impurities well documented and referenced in relevant literature when applying for registration. If the relevant research documents cannot be provided, the compound should be treated as a completely new one. A comprehensive study on its structure, impurities, stability, and necessary process control methods and endpoint inspection standards should be carried out, and other relevant research data should be submitted with other application materials.
At times, solvents may have a more serious impact on the production process and product quality than we imagine, especially when there are variations in the solvent used for refinement of the API pharma, and it may directly affect the solid form of the starting materials. Since the solid state of API pharmaceutical is directly related to its dissolution rate, as well as the release, dissolution rate, and bioavailability of the preparations, changes in solvents may cause changes in the effectiveness and even safety of drugs.
In the early stages of the entire drug manufacturing process, a detailed inspection must be carried out on every link of production, with a simple or complex characterization being performed in each intermediate step. With the development of process techniques and continuous accumulation of work experience, we have found that critical reactions and important intermediates, such as 1 3 dihydroxy acetone and icodextrin, appear more clearly in the entire link of the process. When applying for registration, the key parts of process control, critical steps of intermediates, and the quality standards of the final products that have been established must be included.
It should be emphasized that it is difficult to control the quality of API pharmaceutical by relying solely on the final product quality inspection. Necessary control must be exercised in the intermediate steps of producing drugs. We must consider the issue from the perspective of ensuring the drug quality and minimizing the impurities in the drug. Therefore, the following aspects should be controlled:
The selection of reactants, quality of reagents, and purity should be strictly controlled.
The process control method of intermediates must be established.
Strict verification must be conducted for the production process.
Rigorous endpoint testing must be conducted for API medicines.
In the entire preparation process, reactions that are closer to the final product will have a more significant impact on the quality of the API pharma. Therefore, it is necessary to provide a detailed explanation of the purification process for reactions and crude products. These detailed explanations mainly include process analysis, final yield of crude products, and inspection methods for the final purity of crude products.
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