Assay (bromatometric) | 99.0 - 100.5 % |
Assay (bromatometric, calc. on anhydrous substance) | 99.0 - 100.5 % |
Özdeşlik (IR-spectrum) | Testi geçer |
Özdeşlik (wet chemistry) | Testi geçer |
Appearance | colourless or faintly pink or faintly yellowish crystals or crystalline masses, deliquescent |
Appearance of solution (67 g/l, water) | clear and not more intensely coloured than reference solution B6 |
Acidic substances | Testi geçer |
Solidification temperature | ≥ 39.5 °C |
Fe (Iron) | ≤ 1 ppm |
Benzene (HS-GC) | ≤ 2 ppm |
Methanol (HS-GC) | ≤ 3000 ppm |
Acetone (HS-GC) | ≤ 2 ppm |
Anisole | ≤ 10 ppm |
Cumene (HS-GC) | ≤ 70 ppm |
Methylisobutylketone (HS-GC) | ≤ 2 ppm |
Other residual solvents (ICH (Q3C)) | excluded by manufacturing process |
Residue on evaporation (105 °C, 1 h) | ≤ 0.05 % |
Residue on evaporation (105 °C) | ≤ 0.05 % |
Su (according to Karl Fischer) | ≤ 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 Ph. Eur., ChP, JP, USP |