Chemical process of APIsOne of the important premises for the production of pharmaceutical preparations is APIs, which play an important role in the processing and manufacturing of raw materials in the pharmaceutical industry in all links of the pharmaceutical industry chain. However, most of them are outsourced production. The so-called outsourcing process services for pharmaceuticals refers to pharmaceutical companies entrusting other medical institutions to conduct R&D and production of raw materials outsourcing processes. The production process includes chemical synthesis, fermentation, plant (animal) extraction, etc. Currently outsourcing has become an important purchase and sales model for the global pharmaceutical intermediates and raw materials market, and China has become the world’s largest supply market for raw materials. Most of the raw materials and intermediates needed by foreign formulation manufacturers are Procured in my country. The drug outsourcing process of most of its preparation products, the production process of APIs is much more complicated, the process is long, the pipeline is many, the operation is complicated, and most of the APIs are unstable, such as high requirements for environmental parameters such as temperature, humidity, and light. The raw materials are mostly flammable and explosive. Different from the preparation product process, most of the API production process is a cross-fusion of chemistry and physics, such as product dissolution and decolorization, extraction and adsorption. Because the production of raw materials pays attention to the control of process parameters and environmental parameters, such as light, temperature, and pressure. According to the common classification of source APIs, there are synthetic APIs, animal and plant extract APIs, and APIs obtained from production, fermentation and cell culture; APIs are classified as sterile according to the microbiological level of the product and the target dosage form APIs and non-sterile APIs. The conv Buy Phenibut Online entional API production process is as follows:1. Chemical synthesis API production processIn the chemical raw material production process, various raw materials pass under certain conditions A product with a certain medicinal effect is obtained by chemical reaction, and then through crystallization, drying and other processes to make it reach various indicators of the drug, chemical drug development services, from pre-prescription research, drug analysis, drug stability research, and formulation development. One-stop service including CMC service. The main method of API production is chemical synthesis of drugs. Its chemical structure is generally the target product obtained by a certain step of chemical reaction between the starting material and other compounds, such as condensation, substitution, acylation, redox ; Then go through one or several steps of refining, such as decolorization, recrystallization, etc., to the final API product. The production of intermediates and crude products is mostly carried out in areas without cleanliness, while the finishing process of final products is carried out in clean areas. The design effect of the chemical synthesis API workshop is very important to the production of API manufacturers. Workshop layout is an important part of process design. Only reasonable process layout can achieve advanced process and equipment, and create a good environment for workshop production, operation, equipment installation and maintenance, and for safety, health, and environmental protection. 2. Fermentation API production processProduction process fermentation, especially antibiotic APIs, such as penicillins, cephalosporins, etc., are usually semi-synthetic combined by chemical synthesis And fermented. First, the main structure of the target compound is obtained through biological fermentation, such as the specific 3-lactam structure of penicillin, and then the structure is modified to obta Phenibut Suppliers in the final target compound; finally, the final API product is obtained through purification and recrystallization. The fermentation process generally needs to go through the process of culture medium preparation, tank treatment, inoculation, fermentation, wall breaking, filtration, precipitation, centrifugation, drying and other processes. 3. Sterile API production processSame as sterile preparations, sterile APIs are also divided into terminally sterilized sterile APIs and non-terminally sterilized non-terminally sterilized APIs. However, most of the raw materials are sensitive to high temperature and heat, high humidity and pressure, radiation, etc., so few sterile raw materials are used for terminal sterilization. At present, non-terminally sterilized sterile APIs usually combine the final step of product refining or salt formation with the sterilization process, using pre-filtration plus two-stage 0.22 um sterilization filtration to achieve sterility of the final product. The material liquid after sterilization and filtration is usually crystallized, freeze-dried or spray-dried to obtain the final sterile bulk drug product. In the traditional production of sterile APIs, the dissolution and decolorization of crude products are carried out in a C-level clean area, and sterilization filtration, product formation, centrifugation/filtering, drying, and packaging are performed in a B-level background Of the local A-level environment. At present, aseptic raw materials are increasingly used in closed production, especially the use of three-in-one, isolation, crushing, and packaging equipment integrated isolation, crushing and packaging system, which greatly reduces product contamination by microorganisms or pyrogens Possibility. Therefore, closed sterile API production can also be carried out under the background of C-level, and laminar flow protection or isolation environment is only set up in places where there is a Phenibut powder wholesale risk of local exposure. Compared with non-sterile APIs, the production of sterile APIs not only needs to pay attention to the requirements of chemical quality indicators such as product impurities, physical and chemical properties, but also pay attention to product sterility assurance from the beginning of process design. Therefore, the production of sterile APIs has higher requirements on the environment and equipment4. The production process of animal and plant extraction APIs The nature is a treasure house of natural compounds, and animals or plants pass Its own metabolism produces many compounds that cannot be synthesized at present but are of great significance to the treatment of diseases. Therefore, animal and plant extraction is an important way to obtain target compounds and one of the main ways to produce APIs. For example, artemisinin used to treat malaria and heparin extracted from animal organs used to treat cardiovascular diseases. In recent years, high-level intermediates for the production of APIs have been extracted from animal and plant tissues, and then through certain chemical synthesis and structural optimization, the target compound is finally obtained, which not only greatly improves its efficacy, but also further reduces its toxic and side effects . For example, the anti-cancer drug camptothecin has been further modified to obtain drugs such as irinotecan hydrochloride and topotecan with better selectivity and less toxic side effects. The drug outsourcing process services provided by many pharmaceutical research and development companies provide a guarantee for the process that runs within the predetermined process parameters to continuously and effectively produce drugs that meet the predetermined specifications and quality. In the process of R&D and production of APIs, the production quality management of major drugs is also required. Pharmaceutical production quality management practices are based on production, and quality can only be achieved if there is production. The quality of medicines is produced, not tested, and the production management of medicines is carried out in accordance with GMP. The above information is adapted from the Internet