Specifications | |
---|---|
Assay (acidimetric, calc. on anhydrous substance) | 99.0 - 100.5 % |
Assay (HPLC, calc. on anhydrous substance) | 99.0 - 101.0 % |
Identity | passes test |
Appearance of solution (100 g/l, water) | passes test |
Acidity or alkalinity | passes test |
Chloride (Cl) | ≤ 0.02 % |
Sulphate (SO₄) | ≤ 0.01 % |
Total chlorine | ≤ 0.03 % |
Heavy metals (as Pb) | ≤ 10 ppm |
As (Arsenic) | ≤ 1 ppm |
Cd (Cadmium) | ≤ 10 ppm |
Cu (Copper) | ≤ 10 ppm |
Hg (Mercury) | ≤ 1 ppm |
Pb (Lead) | ≤ 2 ppm |
Zn (Zinc) | ≤ 10 ppm |
Benzene | ≤ 2 ppm |
Toluene | ≤ 890 ppm |
Other residual solvents (ICH Q3C) | excluded by production process |
Multinuclear acids | passes test |
Oxidizable matter | passes test |
Water (according to Karl Fischer) | ≤ 1.5 % |
Residues of metal catalysts or metal reagents acc. to EMEA/C HMP/SWP/4446/2000 are not likely to be present. Conforms to the purity criteria on food additives according to the current European Commission Regulation. | |
Corresponds to Ph Eur,BP,NF,FCC,E 211 |