Specifications | |
---|---|
Assay (permanganometric; calc. on dried substance) | 99.0 - 100.5 % |
Identity | passes test |
Appearance of solution | passes test |
Acidity or alkalinity | passes test |
Chloride (Cl) | ≤ 0.005 % |
Nitrate (NO₃) | ≤ 0.4 % |
Sulphate (SO₄) | ≤ 0.005 % |
Heavy metals (as Pb) | ≤ 0.001 % |
As (Arsenic) | ≤ 0.0003 % |
Ca (Calcium) | ≤ 0.005 % |
Mn (Manganese) (*) | ≤ 0.00025 % |
Ni (Nickel) (*) | ≤ 0.000075 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Loss on drying | ≤ 0.25 % |
* specified acc. to EMEA/CHMP/SWP/4446/2000. Other residues of metal catalysts or metal reagents acc. to this guideline are not likely to be present. | |
Corresponds to Ph Eur, USP |