کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
7687852 | 1495866 | 2018 | 13 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Impact and practicability of recently introduced requirements on elemental impurities
ترجمه فارسی عنوان
تاثیر و کاربرد الزامات اخیرا در مورد ناخالصی های عنصری
دانلود مقاله + سفارش ترجمه
دانلود مقاله ISI انگلیسی
رایگان برای ایرانیان
کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: TrAC Trends in Analytical Chemistry - Volume 101, April 2018, Pages 43-55
Journal: TrAC Trends in Analytical Chemistry - Volume 101, April 2018, Pages 43-55
نویسندگان
Pawel Pohl, Aleksandra Bielawska-Pohl, Anna Dzimitrowicz, Piotr Jamroz, Maja Welna,