Carry over of impurities: a detailed exemplification for glycopyrrolate (NVA237)

…, M Manz, E Gavioli, R Wicky, M Schneider…

Index: Allmendinger, Thomas; Bixel, Dominique; Clarke, Adrian; Di Geronimo, Laura; Fredy, Jean-Wilfried; Manz, Marco; Gavioli, Elena; Wicky, Regine; Schneider, Martin; Stauffert, Fabien J.; Tibi, Markus; Valentekovic, Darko Organic Process Research and Development, 2012 , vol. 16, # 11 p. 1754 - 1769

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Abstract

The original synthesis of glycopyrrolate (NVA237) was revised and shortened into an essentially one-pot process. Without isolating the intermediates, their purification became obsolete, thereby increasing the possibility of the carry over of impurities. For that reason, the actual, potential, and theoretical impurities of the starting materials cyclopentyl mandelic acid and 1-methyl-pyrrolidin-3-ol as well as byproducts which may occur during the ...