مشخصات فنی محصول | |
---|---|
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 | ≤ 10 ppm |
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 (*). | |
Corresponds to DAB 10, FCC |