双(2-氯乙基)胺盐酸盐定量限为0.10 ng·mL-1,加样回收率结果为101.53% (RSD=4.06%);1-(3-氯苯基)-4-(3-氯丙基)哌嗪盐酸盐定量限为0.01 ng·mL-1,加样回收率结果为97.95% (RSD=1.27%).两种遗传毒性杂质在供试品溶液中室温保存24 h内稳定.6批制剂样品和1批原料药中均未检测出双(2-氯乙基)胺,...