Differences and connections between intermediates and APIs

First, the definition is different:

The two definitions in ICH Q7A are as follows:

Intermediate: Intermediate: A material produced in the process steps of the API that must undergo further molecular changes or refining to become the API. Intermediates may or may not be isolated.

Pharmaceutical intermediates are actually some chemical raw materials or chemical products used in the pharmaceutical synthesis process. This kind of chemical product does not require a production license for drugs, and can be produced in ordinary chemical plants. As long as it reaches some levels, it can be used for the synthesis of drugs.

The FDA's summary of the main intermediates is divided into:

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

b. Key intermediates: usually intermediates in which important parts of the molecule are formed for the first time. Such as: an intermediate in which a chiral atom is first introduced into a molecule with stereoisomerism. It can be understood as the main part of drug synthesis.

c. Final intermediate: the previous step in the final reaction of the drug substance synthesis.

Active Pharmaceutical Ingredient (API)(or Drug Substance) – Active Pharmaceutical Ingredient: 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 Element. 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.

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.

Second, the difference in certification:

At present, FDA requires intermediates to be registered, but CEP does not, but the CTD document must have a detailed process description of the intermediate. In China, there is no GMP mandatory requirement for intermediates.

Submitted by API companies, if the API synthesis route is very simple, such as only one-step reaction, the FDA believes that the risk control is insufficient, and it is very likely to extend the inspection of intermediates. The management of intermediates is generally in accordance with ISO or combined with Q7a, and quality system management is sufficient.

3. From the perspective of new drug development, an API is a compound that can be safely used in the human body for therapeutic and diagnostic purposes after sufficient pharmaceutical research; and an intermediate is a compound in the process of synthesizing APIs, which may not necessarily have therapeutic effects or toxicity. . Note that what is said here is not necessarily, the intermediates in the synthesis of some APIs are also APIs.

4. From the perspective of pharmaceutical management, APIs must be registered with the drug regulatory authorities (China Food and Drug Administration in China, FDA in the United States, and EMA in Europe) according to law. It is synthesized in the factory building; and the intermediate is only the intermediate product in the process of synthesizing the API, and does not need to obtain a license number. It should be noted that the same compound as the API does not have a license number or is not produced in a GMP factory, it is not an API.

for example:

Amoxicillin capsules are called preparations, amoxicillin is called API, and 6-APA is called intermediate.

Ceftriaxone sodium powder is called preparation, sterile ceftriaxone sodium is called API, and 7-ACA is called intermediate.

Fifth, the relationship between the two:

1. The specific substances of the two are different

Pharmaceutical intermediates, also known as organic pharmaceutical intermediates, refer to a semi-finished product, which is a product in the production of certain products. The API refers to the active ingredient of the drug, and it is also the basic substance that constitutes the pharmacological action of the drug. API is a pharmaceutical active substance prepared by chemical synthesis, plant extraction or biotechnology.

2. The production of APIs must rely on intermediates

A pharmaceutical intermediate is a chemical raw material or a chemical product in the process of drug synthesis, and is also an intermediate product in the process of producing an API. A substance that must go through the next step of molecular change or refinement to become an API. The API can be directly used as a preparation, while the intermediate can only be used to synthesize the next step product, and the API can be produced only through the intermediate.

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 APIs, you need to obtain a production license for APIs before you can produce them.

To sum up, reliable pharmaceutical intermediates and APIs are two completely different substances. The production of pharmaceutical intermediates has a relatively low threshold, while the production of APIs needs to meet a higher production threshold. If you want to make APIs, you must also have suitable pharmaceutical intermediates as raw materials.

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