如何验证终产品中是否存在漏检杂质研究思路的探讨  

The Study of Two Ways to Verify the Missing Impurity in the Final Product

作　　者：谢沐风[1] XIE Mu-feng(Shanghai Institute for Food and Drug Control,Shanghai 201203,China)

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《药品评价》2018年第4期22-26,共5页Drug Evaluation

摘　　要：过去10年,为了不漏检杂质,全行业树立起"以原料药合成起始物中的杂质作为起点,随后对整个合成路线中有可能存在的杂质展开‘一网打尽、滴水不漏’"的研究理念,从而展开了一场轰轰烈烈的"杂质研究运动"。结果被研究的杂质几乎均是未检出,那些专业"构思"出的杂质更是如此,而这些研究耗费了大量财力资源与精力。那么,科学理性的杂质研究思路应怎样?如何应对漏检杂质?这些问题均将在文中进行研讨,以解开众人疑惑。Over the past10years,in order not to miss the impurities,the whole industry establish API,which starts from the start material in the synthesis of impurities,then the synthetic route of possible impurities on a clean sweep,leak research ideas,and launched a vigorous"impurity study movement".The impurities studied are almost not detected,especially those professional"the idea of"the impurity is so;and these studies have spent a lot of financial resources and energy.So,what should the scientific and rational idea of the study of impurities be?How to deal with the leakage of impurities?These issues will be discussed in the article in order to unravel the people's doubts.

关 键 词：制剂 药品检验 杂质 

分 类 号：R917[医药卫生—药物分析学]