【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。更多还原

【Abstract】 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.更多还原