Elemental impurities guidelines update

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Elemental impurities guidelines update

机译：元素杂质准则更新

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The Elemental Impurities Expert Panel met in September to review the Step 2 limits of the ICH Q3D Elemental Impurities Working Group, which were released in June 2013. At the meeting the panel recommended revisions to General Chapter <232> Elemental Impurities - Limits to partially align with the ICH Q3D limits and other minor changes. The General Chapters - Chemical Analysis Expert Committee met in October and endorsed the recommendations of the Expert Panel.

机译：元素杂质专家小组于9月召开会议，审查了ICH Q3D元素杂质工作组于2013年6月发布的第2步限值。在会议上，专家小组建议对通用章节<232>元素杂质-部分匹配的限值进行修订。 ICH Q3D限制和其他较小更改。通用章节-化学分析专家委员会于10月开会，并认可了专家小组的建议。

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《Cleanroom technology》 |2013年第12期|10-10|共1页
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Elemental impurities guidelines update

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