指导原则解读系列专题(三) 化学药物残留溶剂研究的原则、方法及关注的问题

The principle,method and related questions on study

药物制备中使用的有机溶剂多对人体和环境构成一定的危害,因此需对其在药物中的残留情况进行研究,并加以控制,以保障药物的质量和用药安全。本文根据相关技术指导原则,对残留溶剂研究的原则和方法做了初步介绍,并对技术审评中出现的相关问题进行了归纳与分析,以期更好地服务于残留溶剂的研究。

The organic solvents used in drug manufacturing process often do harm to the environment and human body. Thus the control study for residual solvents in drugs should be developed to maintain the drug＇s quality and safety. In order to serve the research of residual solvents, this article explains the principles and methods of control study for them and sums up real cases under regulatory review based on that enacted guidelines.