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What are the differences between APIs, pharmaceutical excipients, and pharmaceutical intermediates?
Jul 14, 2018

What are the differences between APIs, pharmaceutical excipients, and pharmaceutical intermediates?

API (Active Pharmaceutical Ingredient), a well-defined definition of APIs in ICH Q7A: Any substance or mixture of substances intended for use in the manufacture of pharmaceuticals, and when used in pharmaceuticals, becomes a drug Active ingredient. Such substances may have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of the disease, or may affect the function or structure of the body.

It is the active ingredient of the medicament.

Only raw materials can be processed into pharmaceutical preparations to become a medicine for clinical application.

According to its source, the drug substance is divided into two major categories: chemical synthetic drugs and natural chemical drugs.


The medicinal excipient refers to the collective name of all the medicinal materials except the main drug in the prescription to solve the moldability, effectiveness, stability and safety of the preparation. The formulation process of the pharmaceutical preparation is essentially the process of screening and applying the pharmaceutical excipients according to the characteristics of the drug and the requirements of the dosage form.

        Pharmaceutical excipients are the basic materials and important components of pharmaceutical preparations, and are the material basis for ensuring the production and development of pharmaceutical preparations, and play a key role in formulation dosage form and production. It not only gives a certain dosage form to the drug. Moreover, it has a great relationship with improving the efficacy of drugs and reducing adverse reactions. Its quality reliability and diversity are the basis for ensuring the advanced nature of dosage forms and preparations.


 Medicinal intermediates are so-called pharmaceutical intermediates, which are actually some chemical raw materials or chemical products used in the process of drug synthesis. This chemical product, which does not require a production license for a drug, can be produced in an ordinary chemical plant, and can be used for the synthesis of a drug as long as it reaches a certain level.


Through the above brief introduction of APIs, pharmaceutical excipients and pharmaceutical intermediates, I believe that you have a certain understanding of these three. The completion of the production of finished drugs is inseparable from the raw materials and pharmaceutical excipients; the raw materials are the active ingredients of the drugs, and the pharmaceutical excipients are the formability and stability;

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