Elemental impurities testing and specification limits - ICH Q3D
https://www.europeanpharmaceuticalreview.com/article/82507/elemental-impurities-update-ichq3d/
Web ResultDec 22, 2018 · ICH Q3D allocated PDE (permitted daily exposure) limits for three routes of delivery, ie, oral, parenteral and pulmonary for 24 common elements. These elements were further classified into four categories: Class I: known human toxicants with limited or no use in pharmaceutical manufacture;
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