Separation Science and Technology, Vol.54, No.18, 3005-3018, 2019
Screening commercial available resins for simultaneous removal of two potential genotoxins from API methanolic streams
This paper explores potential API loss mitigation during purification in recrystallization mother liquors, by including a resin adsorption step, to remove potential genotoxin impurities (PGTIs). Mometasone furoate (Meta) is used as model active pharmaceutical ingredient (API) in the presence of 4-dimethylaminopyridine (DMAP) and methyl p-toluenesulfonate (MPTS) as two model PGTIs. AG 50W-X2 and IRA68 resins efficiently removed DMAP and MPTS from methanol solutions, respectively, with adsorptions higher than 93% and Meta binding below 2%. Removal of GTIs using these resins sequentially, or combining them in a single step, was also assessed, with superior results for the later approach.
Keywords:Potential genotoxin impurity;resin adsorbents;4-dimethylaminopyridine;methyl p-toluenesulfonate;active pharmaceutical ingredient purification