Specifications | |
---|---|
Assay (manganometric) | 29.0 - 31.0 % |
Identity | passes test |
Acidity (according to Ph Eur) | passes test |
Acidity (according to USP) | passes test |
Chloride (Cl) | ≤ 0.005 % |
Phosphate (PO₄) | ≤ 0.05 % |
Heavy metals (as Pb) | ≤ 0.0005 % |
As (Arsenic) | ≤ 0.0003 % |
Cu (Copper) | ≤ 0.002 % |
Pb (Lead) | ≤ 0.001 % |
Pd (Palladium)* | ≤ 0.0001 % |
Pt (Platinum)* | ≤ 0.0001 % |
Zn (Zinc) | ≤ 0.002 % |
Residual solvents (ICH Q3C) | ...excluded by production process |
Organic stabilizers | ≤ 0.045 % |
Non volatile matter (105 °C) | ≤ 0.018 % |
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 Contains 0,015 % Na₂H₂P₂O₇, 0,01 % H₃PO₄, 0,006 % NH₄NO₃ as preservatives. |