What Is Difference Between APIs And Intermediates?

Sep. 25, 2021

What are pharmaceutical intermediates?

Pharmaceutical intermediates are fine chemicals that are intermediate compounds produced during the production of active pharmaceutical ingredients (APIs). Intermediates are the by-products of the reactions in the API production process. Each reaction in the production process may produce several intermediates, depending on the analysis, which can be used as precursors for other active pharmaceutical ingredients. The conversion of intermediates to active ingredients can be achieved by further refinement processes. Like APIs, intermediates can also be used as APIs for therapeutic purposes.

4-Chloro-2,6-diaminopyrimidine CAS No.: 156-83-2 is used as an intermediate of the drug Minoxidil, also used in organically synthesized compounds. α-Lipoic Acid CAS No.: 1077-28-7 is used as an intermediate of vitamin drugs, can stimulate fat metabolism. It is used for the treatment of acute and chronic hepatitis, liver cirrhosis, hepatic coma, fatty liver, diabetes, and other diseases.

 

What are APIs in pharmaceuticals?

API (Active Pharmaceutical Ingredient) refers to the active ingredient contained in a drug. For example, a painkiller contains an active ingredient that relieves pain. A small amount of the active ingredient has an effect, so the drug contains only a very small amount of the active ingredient. You can find the name and quantity of the active ingredient in medicine on the packaging of OTC (over-the-counter) medicines.

α-Lipoic Acid CAS No.: 1077-28-7

 α-Lipoic Acid CAS No.: 1077-28-7

How APIs are made?

API and raw material are often confused due to the similar usage of these two terms. What is the difference? The raw material is a compound that is used as the basis for making an API. an API is not made from raw material by just one reaction, but by a variety of compounds that become API. the compounds that are being transformed from raw materials into APIs are called intermediates. Some APIs go through more than ten intermediates in the process of going from raw material to API.

 

The difference between APIs and intermediates

What is the difference between an API and a pharmaceutical intermediate? These terms can be confusing and used interchangeably, especially by those new to the pharmaceutical industry. Although both APIs and intermediates have pharmacological activity, they differ in function, composition, and structure.


4-Chloro-2,6-diaminopyrimidine CAS No.: 156-83-2

 4-Chloro-2,6-diaminopyrimidine CAS No.: 156-83-2

What are the key differences between APIs and intermediates?

Many factors and analyses distinguish active ingredients and compounds from pharmaceutical intermediates. Active ingredients and specialty chemicals are the end products of raw materials, while chemical intermediates are by-products of the API manufacturing process. Unlike APIs, which are usually safe and properly studied for therapeutic purposes, intermediates may be therapeutic, toxic, or even APIs. however, APIs produced as by-products cannot be administered or used as active ingredients without official approval. In addition, unlike active ingredients containing special chemicals, intermediates do not require approval or regulation to be used.

 

Innovation in pharmaceutical intermediates

The pharmaceutical industry is constantly evolving and reinventing itself. A number of pharmaceutical companies and market players are adapting to innovations in the sale of pharmaceutical intermediates, as the demand for them is increasing rapidly. The growth in demand is the result of a combination of factors such as the surge in chronic diseases, which is having a positive impact on the size of the global pharmaceutical intermediates market. As global pharmaceutical activity increases, innovations are being born and demand for pharmaceutical intermediates manufacturers is on the rise. The global pharmaceuticals and packaging market has experienced a surge due to the implementation of regulated pharmaceutical activities, Good Manufacturing Practices (GMP) by pharmaceutical companies.

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