Specifications | |
---|---|
Assay (alkalimetric) | 37.0 - 38.0 % |
Identity | passes test |
Appearance of solution | passes test |
Bromide, Iodide (Br,I) | passes test |
Free bromine or chlorine (NF-meth.) | passes test |
Free chlorine (Cl) | ≤ 0.0001 % |
Sulphate (SO₄) | ≤ 0.0005 % |
Sulfite (SO₃) | ≤ 0.0010 % |
Heavy metals (as Pb) | ≤ 0.0001 % |
As (Arsenic) | ≤ 0.00010 % |
Ca (Calcium) | ≤ 0.0010 % |
Fe (Iron) | ≤ 0.0002 % |
Hg (Mercury) (*) | ≤ 0.000004 % |
Residual solvents (ICH Q3C) | ...excluded by production process |
Residue on ignition (as SO₄) | ≤ 0.008 % |
Evaporation residue | ≤ 0.005 % |
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 (*). | |
Corresponds Ph Eur, BP , JP, NF Expiry date : see product label |