Specifications | |
---|---|
Assay (alkalimetric) | 95.0 - 98.0 % |
Identity | passes test |
Appearance of solution | passes test |
Chloride (Cl) | ≤ 0.0002 % |
Nitrate (NO₃) | ≤ 0.00010 % |
Nitrate (NO₃) (Ph Eur) | passes test |
Heavy metals (as Pb) | ≤ 0.0005 % |
As (Arsenic) | ≤ 0.000010 % |
Fe (Iron) | ≤ 0.0002 % |
NH₄ (Ammonium) | ≤ 0.0005 % |
Pb (Lead) | ≤ 0.0005 % |
V (Vanadium) * | ≤ 0.0002 |
Residual solvents (ICH Q3C) | ...excluded by production process |
Substances reducing potassium permanganate (as SO₂) | ≤ 0.0010 % |
Residue on ignition | ≤ 0.0050 % |
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 to PhEur, BP, JPE, NF Expiry date : see product label |