Differences between pharmaceutical intermediates and APIs

Intermediate is a semi-finished product. In the pharmaceutical field, it is produced in the process of API, but it can not be used directly. It must be further molecular change or refining to become a material of API. It is the product of reaction and can also be the raw material of reaction. Intermediates can be separated or not. It can be seen from the definition that intermediates are the key products of the previous process in the production of APIs, which are different from APIs. There are methods for the detection of API in Pharmacopoeia, but there is no method for the detection of intermediates.

Active pharmaceutical ingredient (API) refers to the API used in the production of various preparations, which is the active ingredient in preparations. It is used in the manufacture of drugs, can be pure or mixture, and when used in medicine, it becomes an active ingredient of drugs. API has 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. API is prepared by chemical synthesis, plant extraction or biotechnology. Only when it is processed into pharmaceutical preparations, can it become a medicine for clinical application.