Selective scavenging of the genotoxic impurity methyl p-toluenesulfonate from pharmaceutical formulations
作者： Rüstem Kecili , Johan Billing , Mats Leeman , David Nivhede , Börje Sellergren
DOI: 10.1016/J.SEPPUR.2012.09.028
关键词:
摘要: Abstract The present study describes an easy and efficient approach for the removal of methyl p-toluenesulfonate, a potentially genotoxic impurity (GTI) from model active pharmaceutical ingredient (API), 21-chlorodiflorasone. For this purpose, several polystyrene–divinylbenzene based silica scavengers were tested which showed highest efficiency selectivity chosen further evaluations. time course GTI API scavenging also capacities different studied in paper. best performance was obtained with Si-Trisamine macroporous MP-Trisamine, both leading to 100% p-toluenesulfonate no loss Non-specifically bound could be recovered quantitatively by using 2-propanol:THF (1:1).
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