The Product Quality Research Institute elemental impurity interlaboratory study: Results and implications for industry
Introduction: Pharmaceutical laboratories experienced a paradigm shift in drug product elemental impurity (EI) expectations in International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline Q3D and United States Pharmacopeia (USP) General Chapters...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-06-01
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| Series: | Journal of Trace Elements and Minerals |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2773050625000187 |
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