Research Article
Development and Validation of Analytical Procedure for Elemental Impurities in Rosuvastatin Calcium Tablets by ICP-MS and Microwave Digestion
Table 3
Permitted daily exposures for elemental impurities established in ICH Q3D.
| | Element | Class | Oral PDE (µg/day) | Parenteral PDE (µg/day) | Inhalation PDE (µg/day) |
| | Cd | 1 | 5 | 2 | 3 | | 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 |
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