酵素胺的杂质概况和稳定性分析:鉴定,基因毒性评估和开发用于关键杂质的UHPLC方法

Burcu Oktar Uzun1, Pelin Kaygu2, Elif Keskin2

  • 1DEVA Holding A.S., R&D Center, Karaağaç Mh. Fatih Blv. No: 26, Kapaklı, Tekirdağ 59510, Türkiye; Ankara University, Graduate School of Health Sciences, Ankara, Türkiye; Ankara University, Faculty of Pharmacy, Department of Analytical Chemistry, Ankara 06560, Türkiye.

概括

这项研究旨在识别和控制前列腺癌药物恩扎胺中的杂质. 它为潜在的基因毒性杂质Enzal-2和Enzal-2A设定了安全限值,以确保药物的质量和患者的安全.