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What Issues Should Be Paid Attention to in the Research on the Preparation Process of APIs?


The preparation of APIs is the initial stage of drug research and development and the basis of drug research and development. It mainly provides detailed information for quality research, provides preparation processes that meet industrial production, and provides pharmacology and toxicology research, preparation research, and clinical research in the process of drug research and development. Provide qualified APIs. Next, let's take a look at what issues should be paid attention to in the research on the preparation process of raw materials?


1. The selection and design of the synthetic route of the API must be based on


In the application registration materials, it is required to explain in detail the background of the research, the basis for the preparation process and route. If it is a drug with a new chemical structure, the basis and principle of the creation should be explained. If it is a generic drug, several different literature routes should be provided for analysis and comparison, detailing the reasons for the route adopted, and explaining how it was improved. and basis for improvement. The evaluation of synthetic routes is aimed at ensuring the stability of product quality, with particular emphasis on the feasibility, controllability, stability, advancement and rationality of process route selection and design.


2. The starting raw materials, reagents and organic solvents must have standards


In the newly issued "Technical Guidelines for Chemical Drug Research", it is also pointed out that raw materials include the starting materials, solvents, catalysts, etc. of the reaction. It also emphasized that the legal source certificate and related process routes and quality standards should be provided for special special intermediates, and the raw materials used in drug production should be purchased from units that meet the regulations.


In the process of API preparation, the quality of starting materials, reagents and solvents is directly related to the quality of the product and the stability of the process route. Different specifications of starting materials, reagents, and solvents will directly affect the process, and different quality of starting materials, reagents, and solvents will introduce different impurities.


3. The intermediate process of API synthesis should be controlled


For the adopted process route, it is required to write out the detailed chemical reaction formula, reaction conditions and operation steps, indicate the input amount, yield, source of raw materials and specifications, and provide a process flow diagram. The end-point control method of each step reaction, the purification and quality control methods of main intermediates and finished products should be explained in detail, and the corresponding data or map should be provided to ensure the quality of the final product. For related substances or other intermediate products that may be produced or mixed in the process, the detection methods and control limits should be explained.


Because the preparation route of organic synthetic drugs is generally long and affected by many factors, specific and detailed operation steps and process conditions are the basis for evaluating the rationality of the process and the feasibility of quality research methods. The control of the intermediate process includes the control of the intermediate and the control of the process conditions.


4. The residues of organic solvents in APIs should be tested


Residual solvents in medicines refer to organic volatile compounds used in the production of API pharma, excipients and preparations that cannot be completely eliminated in the process. Residual solvents are inevitable components in medicines.


5. The research on API technology should emphasize optimization and scale-up


The research on the production process of APIs should include two parts: the laboratory stage and the pilot scale-up. After the small-scale production in the laboratory stage is stabilized, it should be gradually scaled up to the pilot scale. Pilot production is an indispensable link in the transition from laboratory to industrial production, a bridge between the two, and is also of great significance for evaluating the physical property and stability of the process route. Clarify the main tasks of pilot scale-up; pay attention to the evaluation of pilot scale; make it clear that process optimization is a dynamic process; pay attention to the analysis and research of impurities.

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