| Assay (bromatometric) |
99.0 - 100.5 % |
| Assay (bromatometric, calc. on anhydrous substance) |
99.0 - 100.5 % |
| Identity (IR-spectrum) |
passes test |
| Identity (wet chemistry) |
passes test |
| 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 |
passes test |
| 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 % |
| Water (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 |
|
