Study on control of residual solvents in new drugs / 第二军医大学学报

ABSTRACT

At present,there is not a clear guideline for residual solvents in the new drugs in our country. In practice,the ICH Q3C is our important reference in general,but in practical research and evaluation of new drugs,some adjustment should be made on principles of ICH Q3C,making it suitable for the reality of the pharmaceutical industry in our country. In this article, we put forward some suggestions to improve the quality control of residual solvents in our country,and some initial ideas were provided to solve the question in practice.