| Assay (perchloric acid titration, calculated on dried substance) |
98.5 - 101.0 % |
| Identity (IR-spectrum) |
passes test |
| Appearance |
white to almost white, crystalline powder or colorless crystals |
| Appearance of solution (50 g/l; water) |
clear and not more intense in color than reference solution BY₆ |
| Appearance of solution (100 g/l, CO₂-free water) |
clear and colorless |
| Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance) |
+25.5 to +28.5 |
| Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) |
+26.3 to +27.7 |
| Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l,previously dried substance) |
+26.9 to +27.9 |
| pH (100 g/l, CO₂-free water) |
10.5 - 12.0 |
| Chloride (Cl) |
≤ 200 ppm |
| Sulphate (SO₄) |
≤ 200 ppm |
| Heavy metals (as Pb) |
≤ 10 ppm |
| Cu (Copper)* |
≤ 25 ppm |
| Fe (Iron) |
≤ 10 ppm |
| Fe (Iron) (ICP) |
≤ 10 ppm |
| Mn (Manganese) |
≤ 25 ppm |
| Mo (Molybdenum)* |
≤ 2.5 ppm |
| Ni (Nickel)* |
≤ 2 ppm |
| Zn (Zinc) |
≤ 130 ppm |
| Related Compounds, total (TLC) |
≤ 0.5 % |
| Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) |
≤ 0.2 % |
| Ninhydrin-positive substances (LC) (ammonium (570 nm)) |
≤ 0.02 % |
| Ninhydrin-positive substances (LC) (total impurities) |
≤ 0.5 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Sulfated ash (600 °C) |
≤ 0.1 % |
| Loss on drying (105 °C; 3 h) |
≤ 0.30 % |
| Bacterial endotoxins |
≤ 2.0 I.U./g |
| 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., JP, USP. |
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