What is the pharmaceutical intermediate?

pharmaceutical intermediates vs apis

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The pharmaceutical intermediate is a material that produced during the production of APIs. An API is not made by just one reaction, but by several reactions. To produce an API, it can be produced from pharmaceutical intermediates directly to save costs, therefore, the pharmaceutical intermediate is widely used as a key material to produce APIs presently, and certainly it can be also used for research and development purposes.

What is the API?

API stands for active pharmaceutical ingredient, it is the most important ingredient of medicines, it is the actual substance in the medicine that has to do the work in your body. More exactly, such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.

For example, the API in aspirin is acetyl salicylic acid, this API is the actual substance treating your fever or headache. Some medicines carry the name of the API, for example, the API of paracetamol is paracetamol. But in fact, the medicine contains more ingredients than just the API, such as colorants, fillers, binders, preservatives, etc. Those ingredients are called excipients in pharmaceutical industry. Therefore, the FDF (finished dosage forms) generally contains an API alongside various excipients.


What is the difference between the API and the pharmaceutical intermediate?

The API and the pharmaceutical intermediates are both fine chemicals, but as we know that the pharmaceutical intermediate is a material that produced during the production of APIs, they have different functions. After a series of reactions and refining, and with sufficient pharmaceutical research, the API has the therapeutic function, with enough evidences to use in human body safely, while the pharmaceutical intermediate is a middle product produced in production of APIs, it may not have a therapeutic function or may be toxic.

As a chemical materials used in synthesis of APIs, the pharmaceutical intermediate doesn’t need to obtain an approval number and produced in a GMP-compliant plant, after all the API will be produced after refining, but for the API, it must be registered with the drug regulatory authority, like US FDA and Europe EMEA, and it must be produced in a GMP plant.

pharmaceutical intermediates vs apis 1

What else is the pharmaceutical intermediate called?

The pharmaceutical intermediate is also called bulk drug intermediate, API intermediate, Pharmaceutical API Intermediate, drug intermediate, etc.


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