| Assay (complexometric) |
98.0 - 102.0 % |
| Assay (complexometric; calculated on dried substance) |
≥ 99.0 % |
| Identity |
passes test |
| Acidity or alkalinity |
passes test |
| Chloride (Cl) |
≤ 0.0300 % |
| Fluoride (F) |
≤ 0.0030 % |
| Heavy metals (as Pb) |
≤ 0.001 % |
| As (Arsenic) |
≤ 0.0003 % |
| Fe (Iron) |
≤ 0.002 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Na (Sodium) |
≤ 0.2 % |
| Pb (Lead) |
≤ 0.0002 % |
| Se (Selenium) |
≤ 0.0030 % |
| Sr (Strontium) |
≤ 0.05 % |
| Zn (Zinc) |
≤ 0.002 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Loss on ignition (800 °C) |
18.0 - 22.0 % |
| Loss on drying (250 °C) |
≤ 23.0 % |
| 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,E 516 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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