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Impact and practicability of recently introduced requirements on elemental impurities
Trends in Analytical Chemistry ( IF 13.1 ) Pub Date : 2017-09-18 , DOI: 10.1016/j.trac.2017.09.011
Pawel Pohl , Aleksandra Bielawska-Pohl , Anna Dzimitrowicz , Piotr Jamroz , Maja Welna

Spectrochemical elemental analysis of pharmaceuticals and raw materials used for their production will be in the nearest future an obligatory part of quality and safety control for compliance with new standards announced by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Q3D). The present paper surveys R&D articles and scientific papers devoted to determination of the elemental impurities by inductively coupled plasma optical emission spectrometry and mass spectrometry (ICP-OES and ICP-MS) in different pharmaceuticals products that have been published since 2000. In reference to recent changes described in the United States Pharmacopoeia (USP) general chapters <232> and <233>, different aspects of such measurements are presented, including appropriate sample preparation procedures, possible interferences and means of their avoidance, suitable calibration strategies and validation parameters that have to be assessed to prove reliability of the analytical results on the elemental impurities in pharmaceutical products.



中文翻译:

最近引入的元素杂质要求的影响和实用性

药物和用于生产的原料的光谱化学元素分析将在不久的将来成为质量和安全控制的强制性部分,以符合国际人用药品注册技术要求统一委员会(ICH)宣布的新标准Q3D)。本文对自2000年以来发布的不同药品中致力于通过电感耦合等离子体发射光谱法和质谱法(ICP-OES和ICP-MS)测定元素杂质的R&D文章和科学论文进行调查。美国药典(USP)一般章节<232>和<233>中描述的更改,介绍了此类测量的不同方面,

更新日期:2018-03-28
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