| Assay (complexometric; calculated on dried substance) |
98.5 - 100.5 % |
| Identity |
passes test |
| Substances insoluble in acetic acid |
≤ 0.2 % |
| Substances insoluble in hydrochloric acid |
≤ 0.2 % |
| Chloride (Cl) |
≤ 0.025 % |
| Fluoride (F) |
≤ 0.0050 % |
| Sulfate (SO₄) |
≤ 0.25 % |
| Heavy metals (as Pb) |
≤ 0.0020 % |
| Al (Aluminium) |
≤ 0.04 % |
| As (Arsenic) |
≤ 0.0003 % |
| Ba (Barium) |
passes test |
| Cd (Cadmium) (*) |
≤ 0.0001 % |
| Co (Cobalt) (*) |
≤ 0.0001 |
| Cr (Chromium) |
≤ 0.0020 % |
| Cu (Copper) |
≤ 0.001 % |
| Fe (Iron) |
≤ 0.0200 % |
| Hg (Mercury) |
≤ 0.00005 % |
| Mn (Manganese) |
≤ 0.01 % |
| Ni (Nickel) (*) |
≤ 0.0002 |
| Total P (as PO4) |
≤ 0.035 % |
| Pb (Lead) (*) |
≤ 0.0003 % |
| Sb (Antimony) |
≤ 0.0020 % |
| Sr (Strontium) |
≤ 0.03 % |
| V (Vanadium) (*) |
≤ 0.0005 |
| Zn (Zinc) |
≤ 0.001 % |
| Magnesium and alcali salts (at 800 °C) |
≤ 1.0 % |
| Magnesium and alcali salts (at 600 °C) |
≤ 1.5 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Loss on drying (200 °C) |
≤ 2.0 % |
| 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 (*). |
|
| Corresponds to Ph Eur, BP, USP, E 170, FCC Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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