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首页> 外文会议>Separations technology IX: new frontiers in media, techniques, and technologies 2017 >New adsorbers for the removal of genotoxic impurities from active pharmaceutical ingredients
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New adsorbers for the removal of genotoxic impurities from active pharmaceutical ingredients

机译：新型吸附剂，用于从活性药物成分中去除遗传毒性杂质

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摘要

Broad range of chemical families (structural alerts)> Electrophilic species > React with DNA; can lead to strand breaks > Associated carcinogenic risk> Strict regulations (FDA, EMEA) defined a Threshold of Toxicological Concern (TTC): TTC = 1.5 pg/day > TTC corresponds to the probability of one patient in 1,000,000 to manifest the risk of having cancer. > Below the TTC there is no appreciable risk to human health. > GTI limits in APIs are calculated by dividing the TTC value by the maximum daily dose (g/day).
机译：广泛的化学家族（结构警报）>亲电物种>与DNA反应；可能导致链断裂>相关的致癌风险>严格的法规（FDA，EMEA）定义了毒理学阈值（TTC）：TTC = 1.5 pg /天> TTC对应于每100万患者中有一名患者出现癌症。 >在TTC以下，对人类健康没有明显的风险。 > API中的GTI限值是通过将TTC值除以最大每日剂量（g /天）来计算的。

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  • 会议地点 Albufeira(PT)
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    Teresa Esteves; Frederico C. Ferreira; Ana I. Vicente; Carlos A. M. Afonso;

  • 作者单位

    iBB-Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Tecnico, Universida.de de Lisboa, Avenida Rovisco Pais, 1049-001 Lisbon, Portugal;

    iBB-Institutefor Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Tecnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001 Lisbon, Portugal;

    Research Institute for Medicine (iMED, Lisboa), Faculty of Pharmacy, Universidade de Lisboa, Av. Prof. Gama Pinto, 1649-009 Lisboa, Portugal;

    Research Institute for Medicine (iMED, Lisboa), Faculty of Pharmacy, Universidade de Lisboa, Av. Prof. Gama Pinto, 1649-009 Lisboa, Portugal;

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