Specifications | |
---|---|
Assay (perchloric acid titration, calculated on dried substance) | 99.0 - 101.0 % |
Identity | passes test |
Appearance of solution | passes test |
In water insoluble matter | ≤ 0.05 % |
Alkalinity | ≤ 0.2 % |
pH-value (1 %, water) | 8.0 - 9.5 |
pH-value (3 %, water) | 7.5 - 9.2 |
Chloride (Cl) | ≤ 0.01 % |
Sulphate (SO₄) | ≤ 0.0050 % |
Heavy metals (as Pb) | ≤ 0.0010 % |
As (Arsenic) | ≤ 0.0002 % |
Hg (Mercury) | ≤ 0.0001 % |
K (Potassium) | passes test |
Pb (Lead) | ≤ 0.0002 % |
Ca + Mg (calcium and magnesium) | passes test |
free acetic acid | ≤ 0.4 % |
Other residual solvents (ICH Q3C) | excluded by manufacturing process |
formic acid, formate and other oxidizable impurities | ≤ 0.1000 % |
Loss on drying (120 °C) | ≤ 1.0 % |
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. | |
Corresponds to USP, FCC and E 262 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |