What is the difference between API and Pharmaceutical Intermediates?

What is the difference between API (Active pharmaceutical ingredientes) and pharmaceutical intermediates?

API and raw material are often confused due to the similar usage of the two terms.

The main difference between the two is that the API is an active product that has completed the synthesis route, and the intermediate is a product in a certain place in the synthesis route.

Detailed explanation of API and pharmaceutical intermediates

The active pharmaceutical ingredient (API) is the part of any drug that produces the intended effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways. For example, an active ingredient to relieve pain is included in a painkiller. This is called API. A small amount of the active ingredient has an effect, so only a tiny part of the active ingredient is contained in medicine. You will find the name and amount of the active ingredient contained in the medicine on the package of OTC (over-the-counter) drugs.

What is the difference? Raw material refers to chemical compounds that are used as a base to make an API. API manufacturers purchase the raw materials from raw material or chemical product manufacturers both in China and internationally. The API is not made by only one reaction from the raw materials but rather it becomes an API via several chemical compounds. The chemical compound which is in the process of becoming an API from a raw material is called an intermediate. Among the APIs we produce, there is an API which passes through over ten kinds of intermediates in a process when it changes from being a raw material into an API. After this long manufacturing process, it is purified until it reaches a very high degree of purity and finally becomes an API.

Both active pharmaceutical ingredients and intermediates belong to the category of fine chemicals. Intermediates are something that is produced in the manufacturing of API and requires further molecular changes to become APIs. Intermediates can be separated or not separated.

The active pharmaceutical ingredient is used for making medicine and it can be any substance or mixture of substances. When this ingredient is used in medicine, it becomes an active ingredient which plays pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, or prevention of diseases. The APIs can be directly formulated, while intermediates can only be used to synthesize the next product. Only through intermediates can APIs be produced.

It can be seen from the definition that the intermediate pharmaceutical products are the key products of the previous process of making APIs, which are also different in structure from APIs. In addition, the pharmacopeia has testing methods for APIs, but no for intermediates. Active pharmaceutical ingredients and intermediates are both important in the modern pharmaceutical industry.

Wuhan Wingroup Pharmaceutical Custom Sythesis of Intermediates

We have known the difference between the API and pharmaceutical intermediates, and now it is time to know how APIs are produced. This production process usually includes custom synthesis services. We will elaborate on the synthesis of intermediates to uncovers this production process.

First of all, as an API manufacturer we think of how to make a chemical compound which becomes an API in the laboratory. We also have to consider the degree of concentration and which temperature allows a high quality of API to be manufactured efficiently. In order to find answers to these questions, our staff in the development department set about conducting a series of experiments. Once they have decided how to make the compound, our staff in the production department manufacture a high quantity of APIs using the large reactors in our plant. Our quality control staff then conducts analyses in the testing laboratory to examine whether the API manufactured is ultrapure. After testing, our quality assurance staff confirms that everything has been performed correctly in accordance with GMP from manufacturing of API to quality testing. As you can see, a considerable number of staff is involved in the production phase until an API is finally manufactured.

Keywords: #API #activepharmaceuticalingredients #pharmaceutical intermediates #chemical compounds