Specifications | |
---|---|
Assay (calculated on dried substance according to Ph. Eur.) | 98.0 - 101.0 % |
Assay (calculated on dried substance according to USP) | 98.0 - 100.5 % |
Identity | passes test |
Appearance of solution | passes test |
In water insoluble matter | ≤ 0.3 % |
pH-value (5 %; water) | 8.9 - 9.2 |
Chloride (Cl) | ≤ 0.005 % |
Sulphate (SO₄) | ≤ 0.02 % |
Heavy metals (as Pb) | ≤ 0.001 % |
As (Arsenic) | ≤ 0.0002 % |
Fe (Iron) | ≤ 0.001 % |
Sodium dihydrogen phosphate (NaH₂PO₄) | ≤ 1.7 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Substances reducing potassium permanganate (as O) | passes test |
Loss on drying (130 °C) | 19.5 - 21.0 % |
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. | |
Corresponds to Ph Eur, BP, USP |