مشخصات فنی محصول | |
---|---|
Assay (alkalimetric) | ≥ 96.1 % |
Identity | conforms |
Formic acid, Formates and other oxidable impurities (as HCOOH) | ≤ 0.5 % |
Chloride (Cl) | ≤ 0.0003 % |
Sulphate (SO₄) | ≤ 0.0003 % |
Heavy metals (as Pb) | ≤ 0.0005 % |
As (Arsenic) | ≤ 0.0002 % |
Ca (Calcium) | ≤ 0.0005 % |
Fe (Iron) | ≤ 0.0002 % |
Other residual solvents (ICH Q3C) | ...excluded by production process |
Evaporation residue | ≤ 0.02 % |
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). |