| Assay (perchloric acid titration, calculated on dried substance) |
99.0 - 100.5 % |
| Identity (IR-spectrum) |
passes test |
| Identity (Sodium) |
passes test |
| Appearance |
white to almost white, crystalline powder or fine crystals |
| Appearance of solution (100 g/l, water) |
colorless and not more intense in turbidity than control solution according to NF and FCC |
| Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance) |
+24.8 to +25.3 |
| pH (50 g/l CO₂-free water) |
6.7 - 7.2 |
| Chloride (Cl) |
≤ 0.2 % |
| Heavy metals (as Pb) |
≤ 20 ppm |
| Al (Aluminium) |
≤ 5 ppm |
| As (Arsenic) |
≤ 3 ppm |
| Mn (Manganese) |
≤ 15 ppm |
| Pb (Lead) |
≤ 1 ppm |
| Cu (Copper) |
≤ 10 ppm |
| Zn (Zinc) |
≤ 10 ppm |
| 5-Oxopyrrolidine-2-carboxylic acid (Pyroglutamic acid) |
≤ 0.2 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Loss on drying (100 °C, 5 h) |
≤ 0.5 % |
| 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 NF, FCC, E 621Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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