Research advances on drug impurity control and safety evaluation
WANG Weijian
LIU Fei
NIU Chong
XIE Jizhen
ZHU Qingfen
HU Defu
Abstract：As a key factor affecting the safety and effectiveness of drugs,impurity has always been the focus of drug quality research and safety evaluation.This paper focused on the two aspects of drug impurity control and safety evaluation, and summarized the research status of impurity profile,impurity toxicology evaluation,impurity reference substance prepara-tion and so on.
Keywords：Impurity profileToxicology evaluationReference substance
Publication Date：2016-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 657-662 )