What is the difference between API and pharmaceutical intermediates? The main difference between the two is that the API is an active product that has completed the synthesis route, and the intermediate is a product in a certain place in the synthesis route.
Difference between API and pharmaceutical intermediates — detailed explanation
Both active pharmaceutical ingredients and intermediates belong to the category of fine chemicals. Intermediates are something that is produced in the manufacturing of API and requires further molecular changes to become APIs. Intermediates can be separated or not separated.
The active pharmaceutical ingredient is used for making medicine and it can be any substance or mixture of substances. When this ingredient is used in medicine, it becomes an active ingredient which plays pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, or prevention of diseases. The APIs can be directly formulated, while intermediates can only be used to synthesize the next product. Only through intermediates can APIs be produced.
It can be seen from the definition that the intermediate pharmaceutical products are the key products of the previous process of making APIs, which are also different in structure from APIs. In addition, the pharmacopeia has testing methods for APIs, but no for intermediates. Active pharmaceutical ingredients and intermediates are both important in the modern pharmaceutical industry.
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