What is an active ingredient
APIs refer to APIs used in the production of various preparations, which are active ingredients in preparations and substances that patients cannot take directly.
A well-established definition of an API in ICHQ7A: a substance or mixture of substances intended for use in pharmaceutical manufacturing and, when used in pharmaceutical products, becomes an active ingredient of a pharmaceutical product. This substance has pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of disease, or can affect the function or structure of the body.
What is the difference between APIs and intermediates
1. The definition is different
(1) Intermediate: Intermediate: A material generated in the process step of the API that must undergo further molecular changes or refinement to become an API material. Intermediates can be separated or not.
(2) Active Pharmaceutical Ingredient (API) (or Drug Substance) – Active pharmaceutical ingredient: Any substance or mixture of substances intended for use in the manufacture of pharmaceutical products and, when used in pharmaceuticals, becomes an active ingredient of pharmaceutical products. This substance has pharmacological activity or other direct effect in the diagnosis, treatment, symptom relief, treatment 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 pre-process of making APIs, which is different from the structure of APIs. In addition, the pharmacopoeia has methods for the detection of APIs, but there are no intermediates.
2. Differences in certification
(1) Intermediates (FDA) At present, the FDA requires that intermediates must be registered, and CEP does not, but the CTD file must have a detailed process description of the intermediates. Domestically, there is no GMP mandatory requirement for intermediates.
(2) The API is submitted by the API company, if the API synthesis route is very simple, if there is only one step of the reaction, FDA believes that the risk control is insufficient, it is very likely to extend the inspection of intermediates. Intermediates management is generally in accordance with ISO or combined with Q7a, and quality system management is possible.
3. From the perspective of new drug development
(1) API is a compound that can be safely used in the human body for treatment and diagnosis after sufficient pharmaceutical research.
(2) Intermediates are compounds in the process of synthesizing APIs, which do not necessarily have therapeutic effects or are toxic. Note that what is said here is not necessarily, some intermediates in the synthesis process of APIs are also APIs.
4. From the perspective of pharmaceutical affairs management
(1) APIs should apply for registration with the drug regulatory authorities (the State Food and Drug Administration in China, FDA in the United States, and EMA in Europe) in accordance with the law, and synthesize them in GMP-compliant plants after obtaining the approval number.
(2) The intermediate is only an intermediate product in the process of synthesizing APIs, and there is no need to obtain a document number. It should be noted that the same compound as the API has not obtained a document number or is not manufactured in a GMP plant is not an API.
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