Analysis of the difference between intermediates and APIs

Intermediate refers to the intermediate product in the process of compound synthesis. Pharmaceutical intermediates are some chemical raw materials or chemical products used in the synthesis process of APIs. They can be produced in ordinary chemical plants without the production license of APIs As long as it reaches a certain level, it can be used for the synthesis of APIs. The pharmaceutical intermediate industry can provide customized intermediate synthesis services according to customer needs.

Both pharmaceutical intermediates and APIs belong to the field of fine chemicals. Intermediates are materials that are produced in the process steps of APIs and must undergo further molecular changes or refinement to become APIs. Intermediates can be separated or not. (Note: This guide only deals with intermediates produced by the company as defined after the starting point of API production.)

Active pharmaceutical ingredient (raw material): It is intended to be used for any substance or mixture of substances in the manufacture of drugs, and when used in pharmaceuticals, it becomes an active ingredient of drugs. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of diseases, or can affect the function and structure of the body. APIs are active products that have completed the synthetic route, and intermediates are products somewhere in the synthetic route. The API can be directly prepared, and the intermediate can only be used to synthesize the next product. Only through the intermediate can the API be manufactured.
It can be seen from the definition that the intermediate is the key product of the previous process of making the API, and has a different structure from the API. In addition, there are methods for the detection of APIs in the Pharmacopoeia, but there are no intermediates. Speaking of certification, the FDA currently requires intermediates to be registered, but COS does not, but CTD documents require detailed process descriptions of intermediates. In China, there are no GMP mandatory requirements for intermediates.