What Is the Difference between Api and Pharmaceutical Intermediates?

冯宇
3 min readJan 12, 2022

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According to the report, the global pharmaceutical intermediates market was valued at approximately USD 25.44 billion in 2017 and is expected to generate revenues of approximately USD 33,608 million by the end of 2024, growing at a CAGR of approximately 4.0% from 2018 to 2024.

Pharmaceutical intermediates are compounds that form the basic building blocks of active pharmaceutical ingredients (APIs). Pharmaceutical intermediates are by-products of the API manufacturing process. Each reaction in the API manufacturing process produces a variety of different pharmaceutical intermediates. Pharmaceutical intermediates are used in the production of APIs and are also used by various pharmaceutical and biopharmaceutical companies for R&D purposes.

AIBN CAS 78–67–1

What is the difference between API and pharmaceutical intermediates?

The difference between API and pharmaceutical intermediates — Introduction

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

The difference between API and pharmaceutical intermediates — detail

These two kinds of pharmaceutical active ingredients and intermediates belong to the category of fine chemicals. Intermediates are produced in the API manufacturing process and require further molecular changes to become API. intermediates can be isolated or not.

Active pharmaceutical ingredients are used in pharmaceuticals, which can be any substance or mixture of substances. When the ingredient is used in a pharmaceutical, it becomes an active ingredient that exerts pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, or prevention of disease. APIs can be formulated directly; intermediates can only be used to synthesize the next product. Only through intermediates can APIs be produced.

The difference between API and pharmaceutical intermediates — Summary

From the definition, we can see that the intermediate pharmaceutical product is the key product of the pre-process of API, and it is also different from API in structure. In addition, the pharmacopoeia has the test method of API, but there is no test method of intermediates. Active pharmaceutical ingredients and intermediates are both important in the modern pharmaceutical industry.

Custom synthesis of intermediates

We already know the difference between APIs and pharmaceutical intermediates, now it’s time to understand how APIs are produced. This production process usually includes custom synthesis services. We will detail the synthesis of intermediates to shed light on this production process.

Custom synthesis of intermediate pharmaceutical products is divided into 3 levels depending on how closely we work with the customer.

(1) Involvement in the development phase of the client’s new project, which requires a high degree of innovation on the part of the hired company.

(2) Establishment of process routes for scale up production. This requires the company’s ability to engineer and scale up the product, as well as the ability to continuously improve the product in the later stages of customization to meet the needs of large-scale production. Continuously reducing production costs and improving product competitiveness.

(3) Process improvement of products at the customer’s mass production stage to meet the quality standards of foreign companies.

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冯宇
冯宇

Written by 冯宇

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