替罗非班（盐酸盐）

本品与肝素联用，适用于不稳定型心绞痛或非Q波心肌梗塞患者，预防心脏缺血事件，同时也适用于冠脉缺血综合征患者进行冠脉血管成形术或冠脉内斑块切除术，以预防与经治冠脉突然闭塞有关的心脏缺血并发症 Appearance White or almost white powder Solubility Conforms Specific rotation -13.0° ~ -17.0° Identification 1) IR 2) HPLC 3)UV 4) HCl Acidity 2.4 ~ 3.4 Related Substances(HPLC) single impurity: 0.20% Max Total impurities: 0.5% Max Isomer 0.3% Max Water 2.5% ~4.5% Residue on ignition 0.1% Max Heavy metals 20ppm Max Assay (on dried basis) 98.5% Min