The specific difference between intermediates and Intermediate API

In cell biology,Intermediate API an intermediate refers to the middle part of the spindle that is gradually disintegrated near the equatorial plane in the late stage of cell division. The surrounding cytoplasm concentration increases and fills the entire equatorial plane. This thickened area is called an intermediate. The difference between an intermediate and an API: Intermediate: A material that is produced in an API process and must undergo further molecular changes or refinement to become an API. The intermediate can be isolated or not.

API: Active medicinal ingredient (API): Any substance or mixture of substances intended to be used in the manufacture of drugs,Intermediate API and when used in pharmaceuticals, it becomes an active ingredient of drugs. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief,Intermediate API treatment or prevention of diseases,Intermediate API or can affect the function and structure of the body.

It can be seen from the definition that intermediates are the key products of the previous process of making APIs,Intermediate API which are different in structure from APIs. In addition, the pharmacopoeia has testing methods for APIs, but no intermediates. Speaking of certification,Intermediate API the FDA currently requires that intermediates must be registered,Intermediate API while 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. Finally,Intermediate API give an example: amoxicillin capsules are called preparations, amoxicillin is called raw materials,Intermediate API and 6-APA is called intermediates.

Tag: Intermediate API

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