替卡格雷基因毒杂质!?Impurities UL127, UL133 and UL134 (also an important metabolite) are above the qualification level of 0.15% but non-genotoxic. Although the Applicant did not perform the animal qualification study wi ... 您好,请问您提到的这几个杂质基因毒性的参考来自哪里?制剂的进口标准中有杂质 UL127, UL133 和 UL134,没有 AZ13232761和 C3RO, AZ13232761和 C3RO是原料中控制的杂质吗?查看更多