The difference between pharmaceutical intermediates and raw materials

The difference between pharmaceutical intermediates and raw materials

Both pharmaceutical intermediates and APIs belong to the category of fine chemicals. Intermediates are produced in the process steps of APIs and must undergo further molecular changes or refining to become APIs. Intermediates can be separated or not.

API: Any substance or mixture of substances that is intended to be used in the manufacture of a drug and, when used in a drug, becomes an active ingredient of the drug. 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. The raw material drug is an active product that has completed the synthetic route, and the intermediate is a product somewhere in the synthetic route. APIs can be prepared directly, while intermediates can only be used to synthesize next-step products, and APIs can only be produced through intermediates.

It can be seen from the definition that the intermediate is the key product of the previous process of making the raw material drug, which has a different structure from the raw material drug. In addition, there are detection methods for raw materials in the Pharmacopoeia, but not for intermediates.