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肖柏明PPT—杂质研究色谱体系的建立、优化与疑难问题分析

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Two types of interaction products that can be commonly encountered are drug substance–excipientinteractions and drug substance-container / closure interactions Related products Similar chemical structures as the API and may exhibit potentially similar biological activity Degradation products Produced because of position of the material of interest or active ingredient Foreign substances Introduced by contamination or adulteration, not as a consequence of synthesis or preparation, are labeled foreign substances, e.g., pesticides in oral analgesics Table 1 Different terminology used for impurities Review:Forced degradation and impurity profiling: Recent trend in analytical perspectives, Deepti Jian, et. Al. Journal of Pharmaceutical and Biomedical Analysis 68 (2013) 11–35

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