What Is An API Drug? What Is The Difference Between It And The Preparation?

Although many people have heard of APIs, they do not know much about them. Today, I will give you the relevant knowledge of APIs and the difference between APIs and preparations, I hope it will be helpful to you!

First. What is an API?

1. The concept of APIs: APIs refer to the active substances used in the production of preparations, which are the main ingredients processed into preparations, generally made by chemical synthesis, DNA recombination technology, fermentation, enzymatic reactions or extracted from natural substances.

2. Classification of APIs: APIs are divided into non-sterile APIs and sterile APIs.

The API with sterility test items in the quality standard is a sterile API. Sterile raw materials are commonly used in injections and can usually be dispensed directly into injections. However, injectable APIs are not necessarily sterile APIs.

3. The production of APIs includes the following types:

Chemical synthesis: Most APIs are synthesized, such as sulfadiazine.

Extraction: such as heparin extracted from pig intestine, chondroitin extracted from cartilage.

Fermentation: Most antibiotics are derived from the fermentation process, such as penicillin, streptomycin, etc.

A variety of process combinations: such as semi-synthetic antibiotics, steroids, hormones, etc.

Second, the difference between APIs and preparations

1. The production process of APIs is more complicated. The production of APIs often involves complex chemical and biological processes.

2. The production process of APIs often produces by-products.

3. Since APIs will produce by-products, the process of purification and refining is required.

4. The production process of APIs is based on chemical unit reactions and unit chemical operations.

5. Generally speaking, in the production process of preparations, there are few changes in the chemical structure of materials, but in the process of API production, changes in the chemical structure of materials often occur.