What is the difference between pharmaceutical intermediates and APIs?
As can be seen from the definition, the intermediate is the key product of the previous process of making the API, which is different in structure from the API. In addition, there are methods for testing APIs in the Pharmacopoeia, but there are no intermediates. When it comes to certification, currently FDA requires intermediates to be registered, COS does not, but the CTD file must have a detailed process description of the intermediate. In China, there is no GMP mandatory requirement for intermediates.
Both pharmaceutical intermediates and APIs belong to the category of fine chemicals. Intermediates refer to intermediate products in the synthesis process of compounds. Pharmaceutical intermediates are some chemical raw materials or chemical products used in the synthesis process of APIs, which do not require APIs. The production license can be produced in ordinary chemical plants, and as long as it reaches some levels, it can be used for the synthesis of APIs. Active Pharmaceutical Ingredient (API): Any substance or mixture of substances intended for use in the manufacture of a drug product, and when used in a drug product, becomes an active ingredient of a drug product. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptomatic relief, management or prevention of disease, or can affect the function and structure of the body. The API is the active product that has completed the synthetic route, and the intermediate is the product somewhere in the synthetic route. APIs can be directly formulated, while intermediates can only be used to synthesize the next product, and APIs can only be produced through intermediates.