Elemental Impurities in Pharmaceutical Excipients
Elemental Impurities in Pharmaceutical Excipients
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DOI：
10.1002/jps.24650
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发表时间：
2015-12-01
影响因子：
3.8
通讯作者：
Kauffman, John F.
中科院分区：
文献类型：
--
作者：
Li, Gang;Schoneker, Dave;Kauffman, John F.
医药原料中元素杂质的控制目前正在从基于药品成分浓度的控制过渡到基于药品中允许的每日接触量的控制。在药学界，这些变化对药品生产商的影响存在不确定性。造成这种不确定性的部分原因是缺乏关于普通药用辅料中元素杂质水平的公开信息。本文综述了近年来对常用药用辅料和一些原料药中元素杂质含量的调查。开发了一种广泛适用的分析方法，并被证明适用于美国药典章节和国际协调会议Q3D元素杂质指南的元素分析。该方法利用微波辅助消解药物材料和电感耦合等离子体质谱法对这些元素进行定量分析。该程序应用于来自31种不同辅料的190个样品和来自美洲国际药用辅料理事会提供的8种原料药的15个样品。调查结果表明，对于研究中包括的材料，存在相对较低水平的元素杂质。(C) 2015 Wiley期刊公司和美国药剂师协会
Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by a lack of publically available information on elemental impurity levels in common pharmaceutical excipients. This paper summarizes a recent survey of elemental impurity levels in common pharmaceutical excipients as well as some drug substances. A widely applicable analytical procedure was developed and was shown to be suitable for analysis of elements that are subject to United States Pharmacopoeia Chapter and International Conference on Harmonization's Q3D Guideline on Elemental Impurities. The procedure utilizes microwave-assisted digestion of pharmaceutical materials and inductively coupled plasma mass spectrometry for quantitative analysis of these elements. The procedure was applied to 190 samples from 31 different excipients and 15 samples from eight drug substances provided through the International Pharmaceutical Excipient Council of the Americas. The results of the survey indicate that, for the materials included in the study, relatively low levels of elemental impurities are present. (C) 2015 Wiley Periodicals, Inc. and the American Pharmacists Association