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API VS Intermediates: the Difference Between Them

Published:

2022-11-29

What is an intermediate?

An intermediate is an intermediate compound produced during the production of an active pharmaceutical ingredient (API). Pharmaceutical intermediates are by-products produced during the production of APIs. Each reaction in the API production process produces several different intermediates, which can also be used as precursors for other active pharmaceutical ingredients. Intermediates can and are used not only in the production of APIs, but also by various pharmaceutical and biopharmaceutical companies for R&D or therapeutic purposes.

What is an API?

API (active pharmaceutical ingredient) is the active ingredient contained in a drug. Any substance or mixture of substances intended to be used in the manufacture of a drug (drug), when used in the manufacture of a drug, will be the active ingredient in the drug product. Such substances are intended to provide pharmacological activity or other direct action for the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Difference between APIs and intermediates

Although both APIs and intermediates have pharmacological activity, they also have many differences, which are reflected in the following areas.

Applications

APIs are the end product of raw materials that are usually safe and properly studied for therapeutic purposes. Intermediates, on the other hand, are by-products of the API manufacturing process and may be therapeutic, toxic, or even API. API produced as a by-product cannot be administered or used as an active ingredient without official approval.

New Drug Development

APIs are compounds that have undergone adequate pharmacological studies and can be safely used in humans for therapeutic diagnosis. Pharmaceutical intermediates are compounds in the synthesis of APIs that may not have therapeutic effects or are toxic. However, some intermediates in the synthesis of APIs are also APIs.

Drug Regulatory

API must be registered with the drug regulatory authority according to the law and synthesized in a GMP-compliant plant after obtaining an approval number. The intermediate is only a by-product of the API synthesis process and does not need to obtain an approval number. It is important to note that some compounds, although the same as APIs, are not APIs if they do not have an approval number or are not produced in a GMP facility.

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