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What Is An Intermediate? What Is The Difference Between The Drug Substance And The Drug Substance?
- Sep 13, 2018 -

Recently we have been learning vitamins, disperse dyes, bleaches, emulsifiers and more. These are collectively referred to as intermediates, additives, and today this small series focuses on what is called an intermediate, and what is the difference between it and the drug substance.
Intermediates are also known as organic intermediates. Coal tar or petroleum products are used as raw materials to manufacture intermediates of dyes, pesticides, medicines, resins, auxiliaries, plasticizers and the like. Because it was originally used to make dyes, it is also called dye intermediates.

It is formed by a reaction of a cyclic compound such as benzene, naphthalene or anthracene by sulfonation, alkali fusion, nitrification or reduction.

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

It is formed by a reaction of dehydrogenation, polymerization, halogenation, hydrolysis, etc. by an acyclic compound such as methane, acetylene, propylene, butane or butene. For example, butane or butene is dehydrogenated to butadiene, and butadiene can be chemically processed into synthetic rubber, synthetic fibers, and the like. Butadiene is an intermediate.

Originally referred to as the intermediate product produced in the process of synthesizing chemical products such as perfumes, dyes, resins, pharmaceuticals, plasticizers, rubber accelerators, etc. from coal tar or petroleum products. It now refers to the various intermediates obtained during the organic synthesis process.

Intermediates are semi-finished products that are intermediate products in the production of certain products. For example, to produce a product, it can be produced from an intermediate to save costs. Pharmaceutical production requires a large number of special chemicals. Most of these chemicals were originally produced by the pharmaceutical industry. However, with the deepening of social division of labor and advances in production technology, the pharmaceutical industry has transferred some pharmaceutical intermediates to chemical companies for production. Pharmaceutical intermediates are fine chemical products, and the production of pharmaceutical intermediates has become a major industry in the international chemical industry.

In cell biology, intermediates refer to the middle part of the gradual disintegration of the spindle near the equatorial plane in the late stage of cell division. The concentration of cytoplasm increases around the entire equatorial plane. This concentrated region is called an intermediate.
The difference between intermediates and APIs:

Intermediate: A material produced in the process steps of a drug substance that must undergo further molecular changes or refinement to become a drug substance. The intermediates may or may not be isolated.

API: Active pharmaceutical ingredient (API): Any substance or mixture of substances intended for use in the manufacture of pharmaceuticals, and when used in pharmaceuticals, becomes an active ingredient of pharmaceuticals. Such substances may have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of diseases, or may affect the function and structure of the body.

As can be seen from the definition, the intermediate is the key product of the previous process of making the bulk drug, which is different from the structure of the drug substance. In addition, there are methods for the detection of APIs in the Pharmacopoeia, but there are no intermediates. When it comes to certification, the FDA currently requires intermediates to be registered, and COS is not used, but the CTD file contains a detailed description of the intermediate process. Domestically, there are no GMP mandatory requirements for intermediates.

The final example shows that amoxicillin capsules are called preparations, amoxicillin is called bulk drugs, and 6-APA is called intermediates.

Ceftriaxone sodium powder is called a preparation, sterile ceftriaxone sodium is called a drug substance, and 7-ACA is called an intermediate.


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