Q3A(R2): Impurities in New Drug Substances 新原料药中的杂质Q3B(R2): Impurities in New Drug Products (Revised Guideline) 新制剂中的杂质Q3C(R3): Impurities:Guideline for Residual Solvents 杂质:残留溶剂指南Impurities: Guideline for Residual Solvents (Maintenance) 杂质:残留溶剂指南(保留)PDE for Tetrahydrofuran (in Q3C(R3)) 四氢呋喃的PDEPDE for N-Methylpyrrolidone (in Q3C(R3)) N-甲基吡咯烷酮的PDE