A core supporting role in drug synthesis

Category: Industry News

Release date: 2025-10-28

Summary: The synthesis of complex drugs often requires multiple sequential reactions, and the involvement of intermediates can break down the lengthy process into modular units, significantly shortening the reaction timeline. Take the antihypertensive drug "Losartan" as an example: by using the key intermediate 2-n-butyl-4-chloro-5-formylimidazole, the total number of reaction steps can be reduced by 30%, dramatically easing the synthesis process.

Simplifying the path and boosting efficiency

The synthesis of complex drugs often requires multiple sequential reactions, and the involvement of intermediates can break down the lengthy process into modular units, significantly shortening the reaction timeline. Take the antihypertensive drug "Losartan" as an example: by using a key intermediate—2-n-butyl-4-chloro-5-formylimidazole—the total number of reaction steps can be reduced by 30%, dramatically easing the synthesis process.

In terms of improving atom economy, the use of intermediates has also proven highly effective. In traditional processes, aspirin synthesis traditionally starts with phenol as the raw material; however, after optimizing with the intermediate salicylaldehyde, the atom utilization rate increased significantly—from 45% to 72%. Moreover, incorporating chiral intermediates (such as (S)-epichlorohydrin) helps eliminate the need for racemic compound resolution, thereby avoiding wasteful consumption of starting materials and reducing waste emissions by more than 50%, aligning perfectly with the principles of green chemistry.

Ensuring process stability and controllability

Quality control of intermediates is directly linked to the stability of subsequent production processes. Through techniques such as crystallization purification, intermediates can reduce the levels of critical impurities—like genotoxic impurities—to below 0.001%, meeting the requirements of the international ICH Q3A guideline. For instance, in the case of the antiviral drug intermediate sodium phosphonoformate, optimizing the crystallization process reduced batch-to-batch purity variations from ±5% to just ±1.2%, significantly enhancing the robustness of the manufacturing process.

From a cost-control perspective, the judicious use of intermediates can significantly reduce overall production costs. Data shows that compared to traditional processes without intermediate involvement, adopting an intermediate-based production model can cut unit costs by 30.8%, shorten the production cycle by 53.3%, and reduce equipment investment by 40%, thereby making large-scale drug supply economically viable.

Keywords: A core supporting role in drug synthesis

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