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 (*).