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Published in 2020 at "Drug Development and Industrial Pharmacy"
DOI: 10.1080/03639045.2020.1724136
Abstract: Abstract Guideline for Elemental Impurities-Q3D of the International Conference on Harmonisation represents a new paradigm in the control of elemental impurities (EIs) in pharmaceuticals. It changes the approach toward control of EIs from the historical…
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Keywords:
icp;
icp oes;
high daily;
ich q3d ... See more keywords
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Published in 2022 at "PDA journal of pharmaceutical science and technology"
DOI: 10.5731/pdajpst.2021.012655
Abstract: Container closure systems that are used for packaging pharmaceutical products are required to satisfy numerous safety requirements. Maximum permitted limits on the concentrations of numerous toxic elemental impurities that potentially leach from the packaging are…
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Keywords:
glass;
elemental impurities;
elemental impurity;
ich q3d ... See more keywords