在由 HPLC (高效的液相色层分析法) 的 lisinopril 体积药的平淡的杂质侧面期间,潜在的杂质被检测。用多维的 NMR (原子磁性的回声) 技术,踪迹级的杂质明白地被识别是 2-( 在从由半准备的 HPLC 的 lisinopril 体积药的隔离以后的 -2-oxo-azocan-3-ylamino)-4-phenyl-butyric 酸。杂质的形成也被讨论。到我们的知识,这是新奇杂质;没在其它地方报导。
During the routine impurity profile of lisinopril bulk drug by HPLC (high-performance liquid chromatography), a potential impurity was detected. Using multidimensional NMR (nuclear magnetic resonance) technique, the trace-level impurity was unambiguously identified to be 2-(-2-oxo-azocan-3-ylamino)-4-phenyl-butyric acid after isolation from lisinopril bulk drug by semi-preparative HPLC. Formation of the impurity was also discussed. To our knowledge, this is a novel impurity and not reported elsewhere.