Spesifikasyonlar |
Assay (bromatometric, calculated on dried substance) |
98.5 - 101.0 % |
Identity (IR-spectrum) |
passes test |
Appearance |
black to almost black, fine powder |
Appearance of solution (100 g/l, hydrochloric acid 2 mol/l) |
clear and not more intense in color than reference solution Y7 |
Spec. rotation (α 20/D, 20 g/l, hydrochloric acid 1 mol/l, calc. on dried substance) |
-218° to -224° |
Chloride (Cl) |
≤ 0.02 % |
Sulfate (SO4) |
≤ 0.03 % |
Heavy metals (as Pb) |
≤ 0.001 % |
Fe (Iron) |
≤ 0.001 % |
NH4 (Ammonium) |
≤ 0.02 % |
Ninhydrin - positive substances (TLC) |
≤ 0.2 % |
Ninhydrin - positive substances (LC) (largest single impurity) |
≤ 0.2 % |
Residual solvents (Ph. Eur./ICH) |
excluded by manufacturing process |
Sulfated ash (600 °C) |
≤ 0.1 % |
Loss on drying (105 °C) |
≤ 0.5 % |
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. |
Corresponds to Ph. Eur. |