Synthesis and characterization of metabolites and potential impurities of balsalazide disodium, an anti-inflammatory drug

…, MA Baseer, SR Kumar, M Saravanakumar…

Index: Khan, Md. Umar; Baseer; Kumar, S. Ranjith; Saravanakumar; Prasannanjali; Gupta, P. Badarinadh; Kaushik, Vipin K.; Handa, Vijay K.; Islam, Aminul Synthetic Communications, 2010 , vol. 40, # 15 p. 2241 - 2253

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Citation Number: 3

Abstract

Balsalazide disodium (Colazide®) is an oral prodrug of mesalamine (5-aminosalicylic acid) and possesses anti-inflammatory properties. During the process development for balsalazide disodium, we observed eight impurities, namely des-β-alanine balsalazide, balsalazide β-alanine, balsalazide 3-isomer, decarboxy balsalazide, bis-azo salicylic acid, biphenyl-azo salicylic acid, bis-azo diacid, and bis-azo triacid. The present work describes ...