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 the synthesis and characterization of these impurities.

中文翻译：

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巴柳氮二钠（一种抗炎药）的代谢物和潜在杂质的合成和表征

巴柳氮二钠 (Colazide®) 是美沙拉嗪（5-氨基水杨酸）的口服前药，具有抗炎特性。在巴柳氮二钠的工艺开发过程中，我们观察到八种杂质，即脱-β-丙氨酸巴柳氮、巴柳氮β-丙氨酸、巴柳氮3-异构体、脱羧基巴柳氮、双偶氮水杨酸、联苯偶氮水杨酸、双偶氮和双偶氮三酸。目前的工作描述了这些杂质的合成和表征。