Impurities as a key quality attribute of drugs, its research is an important system engineering throughout the research and development process of drugs, and the impurity spectrum analysis is a very important for research of impurity, and has a great guiding significance for the development and optimization of drug preparation process. Only on the basis of comprehensive impurity spectrum analysis, drug quality control could be targeted. The impurity spectrum analysis is also a prerequisite for impurity inspection work and the establishment of reasonable and feasible inspection methods. Based on the author's experience in drug research and development over the past few years, combining the general principles, research ideas and practical work of the chemical synthesis of raw materials were caredinged.
赵 玉，王福生. 原料药的杂质谱分析技术要点探析[J]. 煤炭与化工, 2017, 40(7): 150-152.
Zhao Yu, Wang Fusheng. Discussion on the technical points of impurity profile analysis of synthetic drug substances. CCI, 2017, 40(7): 150-152.
