药物研究中的遗传毒性杂质控制浅析  

Analysis on Control of Genotoxic Impurities in Drug Research

作　　者：张立颖[1] 刘旭亮[2] 郭统山[2] Zhang Liying;Liu Xuliang;Guo Tongshan(Shandong University of Technology,Zibo 255049,China;Shandong Xinhua Pharmaceutical Co.,Ltd.,Zibo 255086,China)

机构地区：[1]山东理工大学,山东淄博255049 [2]山东新华制药股份有限公司,山东淄博255086

出　　处：《山东化工》2020年第1期92-92,96,共2页Shandong Chemical Industry

摘　　要：本文结合浙江华海制药的原料药缬沙坦中的遗传毒性杂质NDMA,介绍了相关的遗传毒性杂质控制的相关法规,并对缬沙坦中NDMA的杂质控制限度进行了计算。The related genotoxic impurities control regulations were introduced in combination with the genetic toxicity impurity NDMA in the valsartan of Zhejiang Huahai Pharmaceutical.The calculation of the genotoxic impurity limits of NDMA in valsartan was performed.

关 键 词：缬沙坦 遗传毒性 NDMA 

分 类 号：TQ460.7[化学工程—制药化工]