Specifications | |
---|---|
Assay (acidimetric, NH₃) | 25.0 - 30.0 % |
Identity | passes test |
Appearance of solution | passes test |
Density (20/20°C) | 0.892 - 0.910 |
Carbonate (as CO₂) | ≤ 0.006 % |
Chloride (Cl) | ≤ 0.00010 % |
Sulphate (SO₄) | ≤ 0.0005 % |
Pyridine and related substances | ≤ 0.0002 % |
Heavy metals (as Pb) | ≤ 0.00010 % |
Cu (Copper) | ≤ 0.00005 % |
Fe (Iron) | ≤ 0.000025 % |
Substances reducing potassium permanganate (as O) | ≤ 0.00075 % |
Residual solvents (ICH Q3C) | ...excluded by production process |
Evaporation residue | ≤ 0.0018 % |
Residue on ignition (as SO₄) | ≤ 0.002 % |
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 (*). |
|
Conforms to Ph Eur, BP |