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Original Articles

Selective Removal of a Pharmaceutical Process Impurity Using a Reactive Resin

, , , , &
Pages 1959-1968 | Received 16 Jan 2003, Accepted 10 Feb 2003, Published online: 02 Jun 2007
 

Abstract

A low‐level (0.5%), but troublesome, aldehyde impurity in a pharmaceutical product was conveniently removed from an existing process stream by employing a reactive, polystyrene‐based sulfonylhydrazine resin. Selection of this resin resulted from screening a number of adsorbents and reactive resins using a high throughput LC–MS approach. The sulfonylhydrazine resin was able to quickly remove an impurity from an existing, highly concentrated, product stream in DMF at a level of 20 mg resin for each gram of product. The material obtained from such treatment showed a greatly improved impurity profile, with an 85% reduction in the level of the aldehyde impurity and without introduction of additional impurities.

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