| Spesifikasyonlar |
| Assay (perchloric acid titration, calculated on dried substance) |
98.5 - 101.0 % |
| Identity (IR-spectrum) |
passes test |
| Appearance |
black to almost black, crystalline powder |
| Appearance of solution (100 g/l, CO2-free water) |
clear and colorless and not more intense in color than reference solution Y7 |
| pH (50 g/l CO2-free water) |
5.9 - 6.4 |
| Chloride (Cl) |
≤ 0.007 % |
| Sulfate (SO4) |
≤ 0.0065 % |
| Heavy metals (as Pb) |
≤ 0.001 % |
| As (Arsenic) |
≤ 0.0002 % |
| NH4 (Ammonium) |
≤ 0.02 % |
| Hydrolyzable substances |
passes test |
| Ninhydrin - positive substances (total (TLC)) |
≤ 0.5 % |
| Residual solvents (Ph.Eur./USP/ICH) class 2 (Methanol) |
≤ 0.3 % |
| Other residual solvents (Ph. Eur./USP/ICH) |
excluded by manufacturing process |
| Loss on drying (105 °C, 2 h) |
≤ 0.2 % |
| Sulfated ash (600 °C) |
≤ 0.1 % |
| Bacterial endotoxins |
≤ 3.0 I.U./g |
| Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. |
| Corresponds to Ph. Eur., BP, JP, USP |