| Assay (perchloric acid titration, calculated on dried substance) |
99.0 - 101.0 % |
| Identity (IR-spectrum) |
passes test |
| Appearance |
white to almost white, fine powder |
| Appearance of solution (25 g/l; CO₂-free water) |
clear and colorless |
| Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance) |
+31.5 to +33.0 |
| Spec. rotation (α 20/D, 40 g/l, water, calc. on dried substance) |
+6.3 to +7.3 |
| pH (25 g/l; CO₂-free water) |
4.0 - 6.0 |
| Chloride (Cl) |
≤ 200 ppm |
| Sulfate (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 |
| Ni (Nickel)* |
≤ 2 ppm |
| Zn (Zinc) |
≤ 130 ppm |
| NH₄ (Ammonium) |
≤ 0.1 % |
| Ninhydrin - positive substances (TLC) |
≤ 0.5 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Sulfated ash (600 °C) |
≤ 0.1 % |
| Loss on drying (105 °C; 3 h) |
≤ 0.3 % |
| 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 DAB, USP |
|
