Structure Assignment of a Pharmacopeial Impurity of Meloxicam

…, A Dancsó, T Bakó, C Peltz, G Simig

Index: Mezei, Tibor; Mesterhazy, Norbert; Bako, Tibor; Porcs-Makkay, Marta; Simig, Gyula; Volk, Balazs Organic Process Research and Development, 2009 , vol. 13, # 3 p. 567 - 572

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Abstract

The most characteristic impurity of the meloxicam drug substance is an N-methylated derivative, equally formed in the various known manufacturing syntheses of the compound. An N-methylated impurity is listed in the European Pharmacopeia monograph of meloxicam as Impurity C, although no evidence has been published for its structure. An unambiguous structure proof of the N-methylated impurity formed in our manufacturing synthesis is ...