What is the difference between an API and an intermediate

intermediates

A substance produced in the process of an API that must undergo further molecular change or refinement to become an API. The intermediate may or may not be separated. (note: this guide only covers intermediates that the company defines as those manufactured after the starting point of API production.)

Active pharmaceutical ingredients

Active Pharmaceutical Ingredient (API) -- Active Pharmaceutical Ingredient (API) : any Substance or mixture of substances intended for use in the manufacture of a Drug, and, when used in pharmaceuticals, as an Active Ingredient in a Drug. This substance has pharmacological activity or other direct effects in the diagnosis, treatment, relief of symptoms, management or prevention of disease, or may affect the function and structure of the body.

The difference between apis and intermediates

As can be seen from the definition, the intermediate is the key product of the previous process of making API, which is different from the structure of API. In addition, the pharmacopoeia has a test method for API, but no intermediate.

From the perspective of new drug development, API is a compound that can be safely used in human body for treatment and diagnosis after adequate pharmaceutical research. Intermediates are compounds in the process of synthesizing apis and may not be therapeutic or toxic. Note that intermediates in the synthesis of some apis are also apis.

From the perspective of drug administration, API should be registered with the drug regulatory authorities (state food and drug administration in China, FDA in the United States and EMEA in Europe) according to law. However, the intermediate is only the intermediate product in the process of synthesizing API, and no document number is needed.

What is the difference between apis and intermediates in the pharmaceutical field? Many people may be confused with apis and intermediates, especially those who are new to the pharmaceutical industry. Now xiaobian for you to talk about the difference between API and intermediate in detail.intermediatesA substance produced in the process of an API that must undergo further molecular change or refinement to become an API. The intermediate may or may not be separated. (note: this guide only covers intermediates that the company defines as those manufactured after the starting point of API production.)Active pharmaceutical ingredientsActive Pharmaceutical Ingredient (API) -- Active Pharmaceutical Ingredient (API) : any Substance or mixture of substances intended for use in the manufacture of a Drug, and, when used in pharmaceuticals, as an Active Ingredient in a Drug. This substance has pharmacological activity or other direct effects in the diagnosis, treatment, relief of symptoms, management or prevention of disease, or may affect the function and structure of the body.The difference between apis and intermediatesAs can be seen from the definition, the intermediate is the key product of the previous process of making API, which is different from the structure of API. In addition, the pharmacopoeia has a test method for API, but no intermediate.From the perspective of new drug development, API is a compound that can be safely used in human body for treatment and diagnosis after adequate pharmaceutical research. Intermediates are compounds in the process of synthesizing apis and may not be therapeutic or toxic. Note that intermediates in the synthesis of some apis are also apis.From the perspective of drug administration, API should be registered with the drug regulatory authorities (state food and drug administration in China, FDA in the United States and EMEA in Europe) according to law. However, the intermediate is only the intermediate product in the process of synthesizing API, and no document number is needed.