Intermediates Vs API

Intermediates and additives are common in our daily life, for example, vitamins, disperse dyes, bleaches and emulsifiers are collectively called Intermediates and additives. Today, this article focuses on introducing what intermediates are and what are the differences between them and API.

Intermediate is also called organic intermediate. Use coal tar or petroleum products as raw materials to manufacture dyes, pesticides, medicines, resins, additives, plasticizers, and other intermediate products. Originally used to make dyes, they are also known as dye intermediates. It is formed by ring compounds such as benzene, naphthalene and anthracene through sulfonation, alkali fusion, nitration and reduction.

For example, benzene is nitrated to nitrobenzene and then reduced to aniline, which can be chemically processed into dyes, drugs, vulcanization promoters, etc. Both nitrobenzene and aniline are intermediates.

It is formed from acyclic compounds such as methane, acetylene, propylene, butane, butene by dehydrogenation, polymerization, halogenation, hydrolysis, etc. For example, butane or butane is dehydrogenated to butadiene, which can be chemically processed into synthetic rubber, synthetic fiber, etc. Butadiene is an intermediate.

The intermediate product that shows to use coal tar or petroleum product to be raw material to synthesize fragrance, dye, resin, medicaments, plasticizer, rubber accelerator to wait for chemical product at the beginning, the intermediate product that produces. Now refers to the process of organic synthesis of various intermediate products.

Intermediates refer to semi-finished products, which are intermediate products in the production of certain products. For example, to produce a product, it can be produced from intermediates to save costs. Drug production requires a large number of special chemicals, most of which used to be produced by the pharmaceutical industry itself. However, with the deepening of social division of labor and the progress of production technology, the pharmaceutical industry has transferred some pharmaceutical intermediates to chemical enterprises for production. Pharmaceutical intermediates belong to fine chemical products, the production of pharmaceutical intermediates has become a major industry in the international chemical industry.

In cell biology, intermediate refers to the area where the cytoplasm increases and fills up the entire equatorial face in the middle of the gradually disintegrating spindle near the equatorial face at the late stage of cell division, and this enrichment area is called intermediate.

Differences between intermediates and APIS:

Intermediate: A substance that occurs during the API process and must undergo further molecular changes or refinement to become an API. The intermediate may or may not be separated.

Active pharmaceutical ingredient (API) : any substance or mixture of substances intended to be used in the manufacture of a drug and, when used in the manufacture of a drug, to be an active ingredient in a drug. Such substances have pharmacological activities or other direct effects in the diagnosis, treatment, relief of symptoms, management or prevention of diseases, or can affect the function and structure of the body.

As can be seen from the definition, the intermediate is a key product of the previous process of making API and is different from the API structure. In addition, the pharmacopoeia has a test method for API, but no intermediate. When it comes to certification, the FDA currently requires intermediates to be registered. COS does not, but the CTD file contains a detailed process description of the intermediates. In China, there is no GMP requirement for intermediates.

Finally, the example shows: Amoxicillin capsule is called preparation, amoxicillin is called API, 6-APA is called intermediate.

Ceftriaxone sodium powder is called preparation, sterile ceftriaxone sodium is called bulk drug, 7-ACA is called intermediate.