Intermediate: A material produced in the process of an active drug substance that must undergo further molecular modification or refinement to become an active drug substance. The intermediate may or may not be separated.
Pharmaceutical intermediates are actually some chemical raw materials or chemical products used in the process of pharmaceutical synthesis. These chemicals, which do not require a pharmaceutical manufacturing license, can be produced in ordinary chemical plants and can be used in the synthesis of medicines as long as they reach a certain grade.
The main intermediatesare divided into:
a. Hub intermediates: intermediates that can be synthesized by different methods.
b. Key intermediate: Intermediate usually formed for the first time in an important part of a molecule. For example, a molecule with stereoisomerism first introduces an intermediate of a chiral atom. It can be thought of as the main part of drug synthesis.
c. Final intermediate: the first step in the final reaction of API synthesis.
API: Any substance or mixture of substances intended to be used in the manufacture of medicines, and when used in medicine, it becomes an active ingredient of medicines. Such substances have 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.
It can be seen from the definition that intermediates are the key products of the previous process of making APIs, and are different in structure from APIs. In addition, the pharmacopoeia has testing methods for APIs, but no intermediates.
An API is a compound that can be safely used in humans for therapeutic and diagnostic purposes after adequate pharmaceutical research. Intermediates, on the other hand, are compounds in the process of synthesizing an active drug substance and may not necessarily have therapeutic or toxic properties. Please note that this does not necessarily mean that some intermediates in API synthesis are also APIs.
The API shall apply for registration with the drug regulatory authority in accordance with the law, and be synthesized in a GMP plant after obtaining the approval number; Intermediates are only intermediate products in the process of synthesis of API, and do not need to obtain approval number. It should be noted that compounds that are the same as APIs that are not labeled or manufactured in a GMP facility are not APIs.
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