Slide TitleBody Text抗生素室原料药中杂质的控制与案例分析中国药品生物制品检定所胡昌勤杂质质控理念的变迁Impurity Profile (杂质谱): A description of the identified and unidentified impurities present in a drug substance. 对存在于药品中所有已知杂质和未知杂质的总的描述纯度