Removal of Acrolein from Active Pharmaceutical Ingredients Using Aldehyde Scavengers

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• 作者：Rustem Kecili ; David Nivhede ; Johan Billing ; Mats Leeman ; B枚rje Sellergren ; Ecevit Yilmaz
• 刊名：Organic Process Research & Development
• 出版年：2012
• 出版时间：June 15, 2012
• 年：2012
• 卷：16
• 期：6
• 页码：1225-1229
• 全文大小：240K
• 年卷期：v.16,no.6(June 15, 2012)
• ISSN：1520-586X

文摘

A variety of chemical compounds, intermediates, and reagents are used during the process of synthesizing active pharmaceutical ingredients (APIs). Some of these chemicals, intermediates, and reagents, as well as byproducts of synthetic processes, can have toxic properties and be present as impurities at low levels in the API or final drug formulation. If present at high concentrations, the toxic impurities could cause adverse health effects in humans. This paper describes a simple and rapid approach for selective removal of acrolein from APIs using iodixanol as a model API. Several scavengers were tested, and the resins which showed highest binding efficiency and selectivity were chosen for further evaluations. The kinetics of acrolein scavenging in the presence of the API iodixanol and the scavenging capacity of resins were demonstrated in this paper. The most complete scavenging is obtained with PS-NHb>2b> which removes 97.8% of acrolein without any substantial removal of the API during 20 min of reaction time.