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杂质作为药品的一项关键质量属性,是贯穿于研发始终的一项重要研究内容。杂质谱分析是杂质研究工作的基础,通过全面的杂质谱分析,可指引药品制备工艺的开发和优化、质量控制策略的制定;可使杂质检查工作有的放矢,是建立合理可行检查方法的基础。本文主要是根据笔者几年来的审评工作经验,结合案例对化学合成原料药的杂质谱分析的一般原则、研究思路进行初步的探讨。
Impurities, as a key quality attribute of pharmaceuticals, are an important part of research and development that has always been carried out in research and development. The analysis of impurity spectrum is the basis of impurity research. Through comprehensive impurity spectrum analysis, it can guide the development and optimization of pharmaceutical preparation process and the formulation of quality control strategy. It can make the impurity inspection work aim at establishing the basis of reasonable and feasible inspection methods. This article is mainly based on the author’s review of work experience over the past few years, combined with the case of chemical synthesis of the general principles of impurity spectrum analysis of raw materials, research ideas for a preliminary discussion.