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药物杂质是反映着药物质量的重要指标，其研究也贯穿着药物研发、生产以及销售的整个过程。随着仪器技术的不断发展，药物中杂质的研究技术以及杂质研究方法也在不断地更新。本文对药物杂质来源、杂质研究方法以及基因毒性杂质研究做出了探讨并重点讨论了研究方法的分析技术以及基因毒性杂质的确定方法，为分析工作者在杂质研究时提供技术上的参考。 As pharmaceutical impurities affect the quality of drugs, whose research is an important aspect of the procedure of drug’s research and development, production and sale. The technology and method renews quickly in pharmaceutical impurities research, which is owing to the continuous development of instruments. The article discusses origins and methods of pharmaceutical impurities and the genetoxic impurities, and mainly describes the development of analytical technique and strategies to assess the genotoxicity of impurities，providing analysts the advice to choose analytical technique. |
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天下1989: 金币+15, ★★★很有帮助 2015-03-04 10:47:41
天下1989: 金币+15, ★★★很有帮助 2015-03-04 10:47:41
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As pharmaceutical impurities affect the quality of drugs, whose research is an important aspect of the procedure of drug’s research and development, production and sale. The technology and method renew【s】 quickly in pharmaceutical impurities research【, which is】 owing to the continuous development of instruments. The article discusses [the] origins and [the study] methods of pharmaceutical impurities, 【and】[as well as] the [in-depth discussion of] genOtoxic impurities, 【and mainly describes】[with the focus on the discussion of] the development of analytical technique and strategies to assess the genotoxicity of impurities，[and ultimately] providing analysts the advice to choose analytical technique. 简单读了下，做了些修改，其中【】为删除者，而[]插入者。genetoxic拼写错误，应该为genotoxic 未作深入修改，仅供参考。 |
2楼2015-03-04 10:21:05
