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The difference between intermediates and APIs:
Jul 14, 2018

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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