机电信息Issue(29)：32-35,52,5.
原料药出HDMF注册文件中的杂质研究
Impurity Study in DMF Registration Documents for Exported APIs
裴中阳 1梁毅1
作者信息
- 1. 中国药科大学国际医药商学院,江苏南京211198
- 折叠
摘要
Abstract
Combining with the requirements of medicine registration and administration in Europe and America,the impurity study methods were described in full-scale,and the concrete analysis methods were presented.Result and conclusion：impurity study is an important content not only in quality control,but also in international registration of medicines.关键词
DMF/杂质研究/分析方法Key words
DMF/impurity study/analysis method分类
化学化工引用本文复制引用
裴中阳,梁毅..原料药出HDMF注册文件中的杂质研究[J].机电信息,2011,(29):32-35,52,5.
