Genotoxic Impurities: Strategies for Identification and Control

John Knight

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Genotoxic Impurities: Strategies for Identification and Control

机译：遗传毒性杂质：识别和控制策略

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The editor, Andrew Teasdale, is a key member of Astra Zeneca's toxicology group, chairing an internal advisory group on genotoxic impurities. He has also been extensively involved in external activities, leading two analytical groups, notably a group in the Product Quality Research Institute where a particular focus was studying the formation and control of sulfonate esters.

机译：编辑安德鲁·蒂斯代尔（Andrew Teasdale）是阿斯特拉·塞内卡（Astra Zeneca）毒理学小组的重要成员，主持了有关遗传毒性杂质的内部咨询小组。他还广泛参与了外部活动，领导了两个分析小组，特别是产品质量研究所的一个小组，该小组特别关注研究磺酸酯的形成和控制。

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《Organic process research & development》 |2011年第3期|共1页
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John Knight;
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中图分类化学工业;
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1. Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: A comprehensive review [J] . Reddy Ambavaram Vijaya Bhaskar, Jaafar Jafariah, Umar Khalid, Journal of separation science. . 2015,第5期

机译：确定药品中潜在遗传毒性杂质的鉴定，控制策略和分析方法：全面综述
2. Genotoxic Impurities: Strategies for Identification and Control [J] . John Knight Organic process research & development . 2011,第3期

机译：遗传毒性杂质：识别和控制策略
3. Application of Quality by Design Principles to Support Development of a Control Strategy for the Control of Genotoxic Impurities in the Manufacturing Process of a Drug Substance [J] . Zadeo Cimarosti, Fernando Bravo, Paul Stonestreet Organic process research & development . 2010,第4期

机译：通过设计原理应用质量支持开发药物制造过程中遗传毒性杂质的控制策略
4. New adsorbers for the removal of genotoxic impurities from active pharmaceutical ingredients [C] . Teresa Esteves, Frederico C. Ferreira, Ana I. Vicente, Separations technology IX: new frontiers in media, techniques, and technologies 2017 . 2017

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
5. Development of Novel Polymeric Ionic Liquid Coatings for the Analysis of Genotoxic Impurities and Diverse Organic Compounds by Solid-Phase Microextraction [D] . Ho, Tien 2014

机译：固相微萃取分析遗传毒性杂质和多种有机化合物的新型聚合物离子液体涂料的开发
6. Development and Validation of LC-MS/MS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials [O] . Yuyuan Chen, Song Wu, Qingyun Yang 2020

机译：LC-MS / MS用于Pan托拉唑原料中潜在遗传毒性杂质分析的开发和验证
7. Identification, synthesis, and characterization of potential genotoxic impurities of sildenafil citrate drug substance [O] . P. Rajesh Reddy, Sivanadh Musunuri, D. Rama Sekhara Reddy, 2020

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8. Genotoxicity of Complex Mixtures: Strategies for the Identification and Comparative Assessment of Airborne Mutagens and Carcinogens from Combustion Sources (Journal Version) [R] . Lewtas, J. 1988

机译：复合混合物的遗传毒性：来自燃烧源的空气致突变物和致癌物的鉴定和比较评估策略（期刊版）

Genotoxic Impurities: Strategies for Identification and Control

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