Assay (argentometric; calculated on dried substance) |
98.0 - 100.5 % |
Identity |
passes test |
Appearance of solution (10 %; water) |
passes test |
Acidity or alkalinity |
passes test |
Heavy metals (as Pb) |
≤ 0.001 % |
As (Arsenic) |
≤ 0.0003 % |
Pb (Lead) |
≤ 0.0002 % |
Ammonium, volatile amines |
passes test |
Ammonium, primary amines |
passes test |
1,4 Dioxane |
passes test |
Residual solvents (ICH Q3C) |
excluded by the manufacturing process |
Residue on ignition |
≤ 0.05 % |
Loss on drying (120 °C) |
≤ 1.5 % |
Water |
≤ 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 (*). |
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Corresponds to DAB 10, FCC |
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