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瀏覽器自帶分享功能也很好用哦~我們在研究藥包材相容性可提取物與浸出物的元素雜質時，依據ICH-Q3D元素雜質中的分類與限值，對藥包材中的金屬元素進行鑒定與風險評估。When studying the elemental impurities of the compatible extracts and extracts of pharmaceutical packaging materials, the identification and risk assessment of metallic elements in pharmaceutical packaging materials were carried out according to the classification and limit of ICH-Q3D elemental impurities.
產品詳情
Element | Class | Oral PDE μg/day | Parenteral PDE, μg/day | Inhalation PDE, μg/day |
Cd | 1 | 5 | 2 | 2 |
Pb | 1 | 5 | 5 | 5 |
As | 1 | 15 | 15 | 2 |
Hg | 1 | 30 | 3 | 1 |
Co | 2A | 50 | 5 | 3 |
V | 2A | 100 | 10 | 1 |
Ni | 2A | 200 | 20 | 5 |
Tl | 2B | 8 | 8 | 8 |
Au | 2B | 100 | 100 | 1 |
Pd | 2B | 100 | 10 | 1 |
Ir | 2B | 100 | 10 | 1 |
Os | 2B | 100 | 10 | 1 |
Rh | 2B | 100 | 10 | 1 |
Ru | 2B | 100 | 10 | 1 |
Se | 2B | 150 | 80 | 130 |
Ag | 2B | 150 | 10 | 7 |
Pt | 2B | 100 | 10 | 1 |
Li | 3 | 550 | 250 | 25 |
Sb | 3 | 1200 | 90 | 20 |
Ba | 3 | 1400 | 700 | 300 |
Mo | 3 | 3000 | 1500 | 10 |
Cu | 3 | 3000 | 300 | 30 |
Sn | 3 | 6000 | 600 | 60 |
Cr | 3 | 11000 | 1100 | 3 |
我們在研究藥包材相容性可提取物與浸出物的元素雜質時，依據ICH-Q3D元素雜質中的分類與限值，對藥包材中的金屬元素進行鑒定與風險評估。When studying the elemental impurities of the compatible extracts and extracts of pharmaceutical packaging materials, the identification and risk assessment of metallic elements in pharmaceutical packaging materials were carried out according to the classification and limit of ICH-Q3D elemental impurities.
產品詳情
Element | Class | Oral PDE μg/day | Parenteral PDE, μg/day | Inhalation PDE, μg/day |
Cd | 1 | 5 | 2 | 2 |
Pb | 1 | 5 | 5 | 5 |
As | 1 | 15 | 15 | 2 |
Hg | 1 | 30 | 3 | 1 |
Co | 2A | 50 | 5 | 3 |
V | 2A | 100 | 10 | 1 |
Ni | 2A | 200 | 20 | 5 |
Tl | 2B | 8 | 8 | 8 |
Au | 2B | 100 | 100 | 1 |
Pd | 2B | 100 | 10 | 1 |
Ir | 2B | 100 | 10 | 1 |
Os | 2B | 100 | 10 | 1 |
Rh | 2B | 100 | 10 | 1 |
Ru | 2B | 100 | 10 | 1 |
Se | 2B | 150 | 80 | 130 |
Ag | 2B | 150 | 10 | 7 |
Pt | 2B | 100 | 10 | 1 |
Li | 3 | 550 | 250 | 25 |
Sb | 3 | 1200 | 90 | 20 |
Ba | 3 | 1400 | 700 | 300 |
Mo | 3 | 3000 | 1500 | 10 |
Cu | 3 | 3000 | 300 | 30 |
Sn | 3 | 6000 | 600 | 60 |
Cr | 3 | 11000 | 1100 | 3 |
滬ICP備2022003614號-1
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