The Relationship between Intermediates and APIs

First, Different definitions.

Intermediates

API process steps produced, must undergo further molecular changes or refining to become an API material. Do not need a drug production license, in the ordinary chemical plant can be produced, as long as the level of some, can be used in the synthesis of drugs.

FDA for the main intermediates are summarized as follows

a. Pivotal intermediates: intermediates that can be synthesized by different methods;

b. Key intermediates: usually the important part of the molecule is formed for the first time intermediates. For example: intermediates with stereoisomeric molecules that introduce chiral atoms for the first time. It can be understood as the main part of drug synthesis.

c. Final intermediate: the step before the final reaction of API synthesis.

Active Pharmaceutical Ingredient (API)

Active Pharmaceutical Ingredient: Any substance or mixture of substances intended to be used in the manufacture of a drug and which, when used in pharmaceuticals, becomes an active ingredient of the drug. This substance has pharmacological activity or other direct effect in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function and structure of the body.

From the definition, it can be seen that the intermediate is the key product of the pre-process of making the API, and the API structure is different. In addition, the pharmacopoeia has the test method of API, but no intermediates.

Second, the therapeutic effect

From the perspective of new drug development, API is a compound that can be safely used in human body for therapeutic and diagnostic purposes after adequate pharmacological research; while intermediates are compounds in the process of synthesizing APIs, which do not necessarily have therapeutic effects or toxicity. Note that here is not necessarily, some API synthesis process intermediates are also API.

Third, approval

From the point of view of pharmaceutical management, API should apply for registration to the drug regulatory authorities (State Food and Drug Administration in China, FDA in the United States, EMA in Europe) according to the law, and obtain the approval number and then synthesize it in a GMP-compliant plant; while intermediates are only intermediates in the process of synthesizing APIs, and do not need to obtain the number. It should be noted that the same compound as the API does not obtain a registration number or is not produced in GMP plants are not APIs.

Fourth, the connection between them

1、Specific substances are different

Pharmaceutical intermediates are a kind of semi-finished products, is the production of certain products in a product. And API refers to the active ingredients of drugs, but also constitute the basis of the pharmacological effects of drugs.

2、The production of API must rely on intermediates

Pharmaceutical intermediates is a chemical raw material or chemical products in the process of drug synthesis, but also the production of API process intermediate products, is a product of the path of synthetic API, is produced in the API process steps, must go through the next step of molecular changes or refining to become an API substance. And API can be used directly as a preparation.

3、Different production requirements

Pharmaceutical intermediates are intermediate products in the process of producing APIs, so pharmaceutical intermediates can be produced in ordinary chemical plants. If you want to produce API, you need to get the production license of API before you can produce it.

To sum up, reliable pharmaceutical intermediates and APIs are two very different substances, the production of pharmaceutical intermediates is relatively low threshold, while the production of APIs needs to meet a higher production threshold. MONADE Medicine owns about 100 kinds of products, we can provide about more than 30000 kinds of products Mainly involves API , pharmaceutical intermediates and natural extract, Please contact us here to get the product lists and quotes.