Study on control of residual solvents in new drugs
- VernacularTitle:新药研究中残留溶剂控制问题的探讨
- Author:
Jie ZHU
;
Hong GU
;
Xueping YIN
- Publication Type:Journal Article
- Keywords:
study on new drugs;
residual solvents;
guideline;
ICH
- From:
Academic Journal of Second Military Medical University
1985;0(05):-
- CountryChina
- Language:Chinese
-
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.
