化学药品杂质研究思路探析

Research thoughts on the impurity of chemical drugs

杂质控制是化学药品质量控制的一项重要内容,研究的总体原则是在分析杂质谱的基础上,建立有效控制方法并制定合理限度。杂质谱的分析主要是基于药物的合成工艺及可能的降解途径;分析方法的建立要重点关注方法的专属性和定量的准确性;杂质限度的确定主要是基于安全性和生产可行性。

Impurity control is a main part of the chemical drug specification. The general principal is to develop effective analytical methods and reasonable limits for analysis of impurity profile. The analysis of impurity profile is based on synthetic routes and possible degradation routes. The development of analytical methods focuses on the specificity and accuracy; the impurity limit is mainly based on safety and manufacturing feasibility.