| Assay (complexometric, MnSO₄·H₂O) |
98.0 - 102.0 % |
| Assay (complexometric, calc. on the ignited basis) |
99.0 - 101.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Chloride (Cl) |
≤ 0.005 % |
| Heavy metals (as Pb) |
≤ 0.002 % |
| As (Arsenic) |
≤ 0.0003 % |
| Ca (Calcium) |
≤ 0.01 % |
| Co (Cobalt)* |
≤ 0.0002 % |
| Fe (Iron) |
≤ 0.001 % |
| Ni (Nickel)* |
≤ 0.0005 % |
| Pb (Lead) |
≤ 0.0004 % |
| Se (Selenium) |
≤ 0.003 % |
| Zn (Zinc) |
≤ 0.005 % |
| Substances not precipitated by ammonium sulfide (as SO₄) |
≤ 0.5 % |
| Residual solvents (Ph Eur/USP/ICH) |
excluded by manufacturing process |
| Loss on ignition (500 °C) |
10.5 - 12.0 % |
| 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, USP, FCC |
|
