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What are differences between API and intermediates?


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Pharmaceutical intermediates: chemical raw materials or chemical products used in the process of pharmaceutical synthesis. They are intermediate products in the process of producing APIs, which can be further processed into APIs. It does not require a production license for APIs, and can be produced in ordinary chemical plants. As long as it reaches a certain level, it can be used for the synthesis of APIs.

 

API : Active Pharmaceutical Ingredient means the active ingredient which is contained in medicine. An active pharmaceutical ingredient (API) is a substance, or a mixture of ingredients, combined in the manufacture of a pharmaceutical or drug. Active pharmaceutical ingredients directly impact disease. Their pharmacological activity plays a direct role in the diagnosis, cure, mitigation, treatment, or prevention of disease. Active pharmaceutical ingredients affect the structure and function of the human body. They are prepared by chemical synthesis, plant extraction or biotechnology, and are used as medicinal powders, crystals, extracts, etc. But the patient cannot take the substance directly. Only when raw materials are processed into pharmaceutical preparations can they be used as clinical drugs. The quality of the drug substance determines the quality of the preparation, so its quality standards are very strict. Countries around the world have formulated strict national pharmacopoeia standards and quality control methods for their widely used drug substances.

 

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.

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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.


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