The difference between pharmaceutical intermediates and apis

Pharmaceutical intermediates and apis both belong to the category of fine chemicals. Intermediates are materials produced in the process steps of apis that must undergo further molecular changes or refining to become apis. Intermediates can be separated or not separated.
Substance: Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical product and, when used in a pharmaceutical product, becomes an active ingredient in the pharmaceutical product. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function and structure of the body. An active drug is an active product that has completed the synthetic path, and an intermediate is a product that is somewhere along the synthetic path. The API can be prepared directly, and the intermediate can only be used to synthesize the next product, and only through the intermediate can the API be manufactured.
As can be seen from the definition, the intermediate is a key product of the previous process of manufacturing the API and has a different structure from the API. In addition, the pharmacopoeia has the detection method of the bulk drug, but there is no intermediate. Speaking of certification, currently the FDA requires intermediates to be registered, COS is not, but the CTD document must have a detailed process description of the intermediates. In China, there is no mandatory GMP requirement for intermediates.