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What are pharmaceutical intermediates?

2023-11-20

What are pharmaceutical intermediates?


Pharmaceutical intermediates are fine chemical products in the production process from pharmaceutical chemical raw materials to bulk drugs or drugs. The synthesis of chemical drugs depends on high-quality pharmaceutical intermediates. This chemical, which does not require a drug production license, can be produced in ordinary chemical plants and can be used in the synthesis of drugs as long as it reaches certain grades. China needs more than 2000 kinds of raw materials and intermediates for chemical industry every year, and the demand is more than 2.5 million tons. After years of development, the chemical raw materials and intermediates needed for pharmaceutical production in China can be basically matched, and only a small part needs to be imported. Moreover, due to abundant resources and low raw material prices in China, many intermediates have been exported in large quantities.




How to divide pharmaceutical intermediate products?


There are many kinds of pharmaceutical intermediates, which can be divided into antibiotic intermediates, antipyretic and analgesic intermediates, cardiovascular intermediates, anticancer intermediates and so on. Specific pharmaceutical intermediates products is very much, such as imidazole, furan, phenolic intermediates, aromatic intermediates, pyrrole, pyridine, biochemical reagents, sulfur, nitrogen, halogen compounds, heterocyclic compounds, microcrystalline cellulose, starch, mannitol, lactose, dextrin, ethylene glycol, powdered sugar, inorganic salts, ethanol intermediates, stearic acid, amino acid and ethanol amine salt, sylvite, sodium salt and other intermediates and so on.


In addition, in recent years due to the drug regulatory requirements is more and more strict, pharmaceutical research difficulty increasing, rising prices such as background, the multinational pharmaceutical enterprises to shorten time to market, patent medicine research and development, production to reduce costs, in the whole life cycle of good profit space, to improve their management efficiency, gradually from the "vertical integration" business model to the "development and cooperation" business model transformation, the patent medicine research, development, production and other business link professional decomposition, and outsourcing to the medical contract research, medicine and custom research and development production enterprises, professional institutions, such as the medical custom research and development production (CMO)




Model Selection Guide


Pharmaceutical intermediate is a kind of chemical raw material or chemical product used in pharmaceutical synthesis. This chemical, which does not require a drug production license, can be produced in ordinary chemical plants and can be used in the synthesis of drugs as long as it reaches certain grades. It includes the classification of chemical agents, such as ammonium phenyl dysprosium, ferrite, lipazolium, etc. The very large part of the intermediate belongs to the semi-finished products, which belong to the initial products in the process and must be processed by a certain process, that is, the industrial materials, not the final products. Pharmaceutical intermediates belong to fine chemical products, the production of pharmaceutical intermediates has become a major industry in the international chemical industry. At the same time, as a semi-finished product, pharmaceutical intermediates belong to fine chemical products, the production of pharmaceutical intermediates has become a major industry in the international chemical industry.


Commonly used in pharmaceutical intermediates, 2 - ethyl furan truxene 3, 5 - two br - 4 - hydroxy benzoic acid, 4 - methyl - 3 - nitrobenzene methyl ether lyrica ene alkynol mitotane N - chlorinated phthalein imide 6 - fluoro - 3 - piperidine - 4 - base - 1, 2 - benzo thiazole hydrochloride, in terms of production, most of the domestic enterprises in the initial stage, and there are certain gaps when compared with European and American pharmaceutical giant. At the same time, compared with API, the profit margin of pharmaceutical intermediates production is low, and the production process of API and pharmaceutical intermediates is similar. Therefore, some enterprises have not only produced intermediates, but also started to produce API by taking advantage of their own advantages.



How to improve the production process of pharmaceutical intermediates, reduce the production cost, and find a suitable route to produce API, will undoubtedly get more profits. The pharmaceutical intermediates are generally analyzed by means of INFRARED spectroscopy (FTIR), nuclear magnetic resonance (1H NMR), mass spectrometry (MS), X-ray diffraction analysis (XRD), ICP-MS, X-ray fluorescence spectroscopy and ion chromatography. By means of these testing methods, the formulation of pharmaceutical intermediates can be well analyzed, and the function of components in pharmaceutical intermediates can be understood in detail, which is more convenient for enterprises to carry out research and development and grasp the market dynamics. Zhe rich rely on zhejiang university discipline advantage and analyze talent, has a variety of analysis methods, the accumulated deep analyze the experience of chemical products, through professional, reliable and comprehensive means of separation and detection of unknown material qualitative appraisal and quantitative analysis, adjust the formula, for scientific research and production of new products research and development, provide a scientific basis for improving production technology, can also according to customer needs, provide late tracking technical guidance.









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