The Difference Between API Pharmaceutical and Intermediates and Pharmaceutical Preparations

1. The difference between intermediates and API pharmaceutical

Intermediate: a material produced in the API pharmaceutical process steps that must undergo further molecular changes or refining to become a material of API pharmaceutical; intermediates can be separated or not separated: API pharmaceutical: that is, active pharmaceutical ingredients: refers to those used in pharmaceuticals Any substance or mixture of substances in the manufacture and, when used in medicine, becomes an active ingredient of a medicine. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptomatic relief, management or prevention of disease, or can affect the function and structure of the body.

It can be seen from the definition that intermediates are the key products of the previous process of making API pharmaceutical, which is different from API pharmaceutical in structure; in addition, there are testing methods for API pharmaceutical in the Pharmacopoeia, but there are no intermediates; when it comes to certification, currently FDA It is required that intermediates must be registered, but COS is not required, but the CTD document must have a detailed process description of the intermediates; in China, there is no GMP mandatory requirement for intermediates.

Finally, give an example: Amoxicillin capsules are called preparations, amoxicillin is called API pharmaceutical, and 6-APA is called an intermediate. Ceftriaxone sodium powder is called preparation, sterile ceftriaxone sodium is called API pharmaceutical, and 7-ACA is called intermediate. If you are looking for pharmaceutical ingredients manufacturers, Pharmasources would be a great platform for you.

2. The difference between pharmaceutical preparations and API pharmaceutical:

Compared with pharmaceutical preparations, the production process of API pharmaceutical has its own characteristics. The production of API pharmaceutical often involves complex chemical changes and biological changes, with complex intermediate control processes. The production process often produces by-products, which usually requires a purification process. Different types of production equipment and operating processes are very different, and the same reaction equipment is usually used for different reactions. With the development of science and technology, automated production facilities and online monitoring systems are increasingly used in the production of API pharmaceuticals. However, due to the limitations of cognition, the mechanisms of some chemical reactions and biological reactions have not been fully understood.

The process of API pharmaceutical is complex and diverse. Some processes are long, such as steroid hormones, and some are relatively short, such as extraction. Generally speaking, there is a refining process in the production process of API pharmaceutical. The main purpose of this process is to remove impurities in API pharmaceutical. The production process of API pharmaceutical is based on one chemical unit reaction and one unit chemical operation. Generally speaking, in the production process of preparations, the chemical structure of materials rarely changes, but in the production process of API pharmaceutical, chemical structure changes of materials often occur.