摘 要：目的 分析探讨化学药物杂质研究中风险控制的相关问题。方法 通过分析、归纳杂质研究的目的、内容及其一般过程，探讨药物杂质研究的基本规律和相关要素。结果 科学的分析方法、严格的杂质限度、严谨的过程控制是药物杂质研究中风险控制的关键要素。结论 通过选择合适的分析方法，准确分辨与定量杂质，综合药学、毒理学及临床研究的结果，确定合理的杂质限度，通过对原辅料的源头控制措施、制备工艺的过程控制措施、包装材料、贮藏条件及有效期的确立等终端控制措施，将杂质控制在安全合理的范围内，正是杂质研究的最终目的。

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．