Difference between intermediate and API

Intermediate: a kind of material produced in the process of API, which must undergo further molecular change or refining to become API. Intermediates can be separated or not.

Drug substance: active pharmaceutical ingredient (drug substance): any substance or mixture of substances intended for use in the manufacture of drugs, and when used in pharmaceuticals, it becomes an active ingredient of drugs. This substance has pharmacological activity or other direct effects in disease diagnosis, treatment, symptom relief, treatment or disease prevention, or can affect the function and structure of the body.

As can be seen from the definition, intermediates are the key products of the previous process for the preparation of APIs, which are different from the structure of APIs. In addition, the Pharmacopoeia has a method for the detection of APIs, but no intermediates. When it comes to certification, at present, FDA requires that intermediates must be registered, while cos does not. However, CTD documents should have a detailed process description of intermediates. In China, there is no mandatory GMP requirement for intermediates.

Finally, for example: amoxicillin capsule is called preparation, amoxicillin is called API, and 6-APA is called intermediate.

Ceftriaxone sodium powder injection is called preparation, sterile ceftriaxone sodium is called API, and 7-ACA is called intermediate.