摘 要：目的 分析探討化學(xué)藥物雜質(zhì)研究中風險控制的相關(guān)問題。方法 通過分析、歸納雜質(zhì)研究的目的、內(nèi)容及其一般過程，探討藥物雜質(zhì)研究的基本規(guī)律和相關(guān)要素。結(jié)果 科學(xué)的分析方法、嚴格的雜質(zhì)限度、嚴謹?shù)倪^程控制是藥物雜質(zhì)研究中風險控制的關(guān)鍵要素。結(jié)論 通過選擇合適的分析方法，準確分辨與定量雜質(zhì)，綜合藥學(xué)、毒理學(xué)及臨床研究的結(jié)果，確定合理的雜質(zhì)限度，通過對原輔料的源頭控制措施、制備工藝的過程控制措施、包裝材料、貯藏條件及有效期的確立等終端控制措施，將雜質(zhì)控制在安全合理的范圍內(nèi)，正是雜質(zhì)研究的最終目的。

Abstract: Objective To analyze and discuss the related factors in the risk control of chemical drug impurity. Methods The basic rule and related factors of drug impurity control were discussed，and the purpose, content and general process of the impurity study were analyzed．Results Scientific analytical method，strict impurity limit and critical process control are the key factors in the risk control of drug impurity．Conclusion Appropriate analytical method，reasonable impurity limit，accurate impurity identification and determination are very important in the control of drug impurity．In addition，pharmacological，toxicological and clinical studies should be combined at the same time．Through source control measures of raw materials and excipients，process control measures of preparation process and terminal control measures in packing materials，storage condition and shelf life，impurity can be well controlled within safe and reasonable range．