01.11.2022

What is the difference between API and pharmaceutical intermediates? The main difference between the two is that the API is an active product that has completed the synthesis route, and the intermediate is a product in a certain place in the synthesis route.

Difference between API and pharmaceutical intermediates — detailed explanation

Both active pharmaceutical ingredients and intermediates belong to the category of fine chemicals. Intermediates are something that is produced in the manufacturing of API and requires further molecular changes to become APIs. Intermediates can be separated or not separated.


The active pharmaceutical ingredient is used for making medicine and it can be any substance or mixture of substances. When this ingredient is used in medicine, it becomes an active ingredient which plays pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, or prevention of diseases. The APIs can be directly formulated, while intermediates can only be used to synthesize the next product. Only through intermediates can APIs be produced.


It can be seen from the definition that the intermediate pharmaceutical products are the key products of the previous process of making APIs, which are also different in structure from APIs. In addition, the pharmacopeia has testing methods for APIs, but no for intermediates. Active pharmaceutical ingredients and intermediates are both important in the modern pharmaceutical industry.


Custom synthesis of intermediates

We have known the difference between the API and pharmaceutical intermediates series, and now it’s time to know how APIs are produced. This production process usually includes custom synthesis services. We will elaborate on the synthesis of intermediates to uncovers this production process.


Custom synthesis of intermediate pharmaceutical products is divided into 3 levels according to the closeness of cooperation with customers:


(1)Participating in the development stage of the customer’s new project, which requires the company hired to be highly innovative;


(2)Setting up the process route of large-scale production. This requires the company’s engineering amplification capabilities of the product and the ability to continuously improve the process of customized products in the later stage to meet the needs of large-scale production. Continuously reduce production costs and improve product competitiveness;


(3) Process improvement of the products in the mass production stage of customers, so as to meet the quality standards of foreign companies.


Molcreator is a chemical synthesis lab which can design synthetic routes for customers’ target molecules, and complete the synthesis and delivery of compounds in time with high quality ensured. These compounds include reference compounds, metabolites, reagents, intermediates, molecular fragments and impurities, etc.


Fine Chemicals, Intermediates and Excipient

The basic principle for definition of the term. Fine Chemicals is a three-tier segmentation of the universe of chemicals into commodities, fine chemicals, and specialty chemicals


Fine chemicals are complex, single, pure chemical substances. They are produced in limited quantities (<1000 metric tons per year) in multipurpose plants by multistep batch chemical or biotech(nological) processes.


Pharmaceutical intermediates are chemical compounds which form the building blocks of the active pharmaceutical ingredient (API).


Pharmaceutical intermediates are produced as a by-product during the production of API. Every reaction in the production process of API gives rise to various different pharmaceutical intermediates. Pharmaceutical intermediates are used in the production of bulk drugs and also for research and development purpose by various pharma and biopharma companies.


The pharmaceutical industry is ever thirsty to satisfy patient’s therapeutically needs and apart from active ingredients, inactive excipients play a major role in formulation development. Pharmaceutical excipients are substances other than the pharmacologically active drug or prodrug which are included in the manufacturing process or are contained in a finished

pharmaceutical product dosage form.

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