Elemental Impurities

Elemental Impurities Manufacturer, Supplier

Elemental impurities analysis encompasses trace metal /heavy metal testing to evaluate pharmaceutical products for elevated concentrations of elements such as lead and arsenic that are of significant toxicological concern. The elemental impurities are grouped into three classes

• Class 1 (As, Cd, Hg, and Pb) - Human toxicants with limited or no use in pharmaceutical manufacturing
• Class 2
  Class 2A (Co, Ni, V) - Relatively high probability of occurrence in the drug product
  Class 2B (Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, Tl) - Relatively low probability of occurrence in the drug product
• Class 3 (Ba, Cr, Cu, Li, Mo, Sb, Sn) - Relatively low toxicities

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