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Distinction between API, pharmaceutical excipients and pharmaceutical intermediates
Jun 11, 2018

The perfect definition of API in ICH Q7A: a mixture of any substance or substance used in the manufacture of a drug, and a active component of the drug when used in the pharmaceutical industry. This substance has pharmacological activity or other direct effects in the diagnosis of disease, treatment, relief of symptoms, treatment or prevention of disease, or can affect the function or structure of the body.

An effective component of a drug. Only when the API is processed into a pharmaceutical preparation can it become a medicine for clinical use.

As stipulated in the Chinese Pharmacopoeia, medical excipients refer to all medicinal materials except the main medicine in order to solve the formulation, the validity, the stability and the safety of the formulation when the formulation is designed. The formulation process of drug formulation is in essence the process of screening and applying pharmaceutical excipients according to the requirements of drug characteristics and dosage forms.

The so-called pharmaceutical intermediates, also known as medicinal intermediates, are actually intermediate products such as raw materials, materials and excipients used in the process of producing pharmaceutical products. In fact, some chemical raw materials or chemical products are used in the process of drug synthesis. This chemical product, which does not require a production license of a drug, can be produced in a common chemical plant and can be used for the synthesis of drugs as long as it reaches some level.

We can see that the API, medicinal excipients and medicinal intermediates are used to produce the finished products. The difference is that the three are the products of different stages, and the raw materials are the closest to the finished products. The general manufacturer buys the raw material medicine, carries on the processing to it, adds the corresponding medicine excipient, after processing has become the finished product medicine. The intermediates are the precursors of the APIs, and are the products of various stages before supporting the API.