阿德福韦双匹酯有机溶剂残留量检测方法学研究

The Text on the Validation of Determining Procedures of Residual Solvents in Adefovir Dipivoxil

阿德福韦双匹酯的合成工艺需用到多种有机溶剂。其有可能残留甲醇、乙腈和醋酸异丙酯,因此需对产品中这三种有机溶剂的残留量进行检测。本文对检测阿德福韦双匹酯甲醇、乙腈和醋酸异丙酯残留量的方法学进行了研究。

Methanol, acetonitrile and isopropyl acetate are used in the manufacture of Adefovir dipivoxil. The content of these residual solvents in the API should be determined. This paper reports the text on the validation of determining procedures of these residual solvents in adefovir dipivoxil