Specifications | |
---|---|
Assay (argentometric; calculated on dried substance) | 99.5 - 100.5 % |
Identity | passes test |
Appearance of solution | passes test |
Acidity or alkalinity | passes test |
Bromide (Br) | ≤ 0.005 % |
Ferrocyanides | passes test |
Iodide (I) | passes test |
Nitrite (NO₂) (UV-absorption 354nm; 1cm; 10%; water) | ≤ 0.01 |
Phosphate (PO₄) | ≤ 0.0025 % |
Sulphate (SO₄) | ≤ 0.0200 % |
Heavy metals (as Pb) | ≤ 0.0005 % |
As (Arsenic) | ≤ 0.0001 % |
Ba (Barium) | passes test |
Ca (Calcium) | ≤ 0.002 % |
K (Potassium) | ≤ 0.01 % |
Fe (Iron) | ≤ 0.0002 % |
Magnesium and alkaline-earth metals (as Ca) | ≤ 0.0100 % |
Residual solvents (ICH Q3C) | excluded by the manufacturing process |
Loss on drying (105 °C, 2 h) | ≤ 0.5 % |
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 Ph Eur, BP, USP |