Articles with "ich q3d" as a keyword



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ICH Q3D based elemental impurities study in liquid pharmaceutical dosage form with high daily intake – comparative analysis by ICP-OES and ICP-MS

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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… read more here.

Keywords: icp; icp oes; high daily; ich q3d ... See more keywords
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Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma-Mass Spectrometry.

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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… read more here.

Keywords: glass; elemental impurities; elemental impurity; ich q3d ... See more keywords