Kymos Group has an experienced team dedicated solely to elemental impurities and equipped with two Ion Coupled Plasma Mass Spectrometers (ICP-MS) Agilent (7700, 7800) with high capacity autosamplers and Atomic Absorption (Varian 240 FS with graphite furnace and hydride generator) as well as two Ultrawave digestion systems from Milestone.
The European Pharmacopoeia and USP General Chapters are <232>, <233> and <2232> for drug substances, excipients and drug products, requires most drugs, including those for veterinary use, to be tested for the potential presence of the 24 elemental impurities listed in the ICH Q3D guideline.
List of Elemental Impurities we can test
| Class 1 | Class 2A | Class 2B | Class 3 | Others |
|---|---|---|---|---|
| Cd, Pb, As, Hg | Co, V, Ni | Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt | Li, Sb, Ba, Mo, Cu, Sn, Cr | Al, B, Ca, Fe, K, Mg, Mn, Na, W, Zn… |
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Our Methodology and Compliance
ICH Q3D is subject to constant revision and updating and our experienced elemental impurities team is constantly keeping up to date.
It is not only pharmaceutical guidelines that give our elemental impurities team the right direction. The determination of elemental impurities is also becoming increasingly important in the cosmetics sector.
Moreover, our elemental impurities team continues to develop additional assays to comply with new regulatory requirements:
Related Services
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