| Assay (iodometric, FeCl₃·6H₂O) |
99.0 - 102.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Appearance of solution (JPE) |
passes test |
| Acidic substances |
passes test |
| Basic salts |
passes test |
| Free chlorine |
passes test |
| Nitrate (NO₃) |
passes test |
| Sulfate (SO₄) |
≤ 0.005 % |
| Heavy metals (as Pb) |
≤ 0.005 % |
| As (Arsenic) |
≤ 0.0002 % |
| Co (Cobalt)* |
≤ 0.00005 % |
| Cu (Copper) |
≤ 0.005 % |
| Fe II (Iron II)* |
passes test |
| Hg (Mercury)* |
≤ 0.00003 % |
| Mn (Manganese) |
≤ 0.05 % |
| Na (Sodium) |
≤ 0.05 % |
| Ni (Nickel)* |
≤ 0.0002 % |
| Pb (Lead) |
≤ 0.005 % |
| Zn (Zinc) |
≤ 0.005 % |
| Substances not precipitated by ammonia (as sulfates) |
≤ 0.1 % |
| Residual solvents (Ph Eur/USP/ICH) |
excluded by manufacturing process |
| 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 (*). * The Fe(II)-content increases if the recommended storage conditions (+15 to +25°C) are not observed. conforms to Ph Eur, JPE |
|
| conforms to Ph Eur, JPE |
|
