Assay (acidimetric, calc. on anhydrous substance) | 99.0 - 101.0 % |
Assay (HPLC, calc. on anhydrous substance) | 98.0 - 102.0 % |
Özdeşlik | Testi geçer |
Appearance of solution (5 %; ethanol 96 %) | Testi geçer |
Melting range (lower value) | ≥ 133 °C |
Melting range (upper value) | ≤ 135 °C |
Heavy metals (as Pb) | ≤ 0.0010 % |
As (Arsenic) | ≤ 0.0003 % |
Cd (Cadmium) | ≤ 0.001 % |
Cu (Copper) | ≤ 0.001 % |
Hg (Mercury) | ≤ 0.0001 % |
Pb (Lead) | ≤ 0.0002 % |
Zn (Zinc) | ≤ 0.001 % |
Aldehydes (as Acetaldehyd) | ≤ 0.15 % |
Acetone | ≤ 5000 ppm |
Other residual solvents (ICH Q3C) | excluded by the manufacturing process |
Thermal stability (105 °C) | No coloration |
Loss on drying | ≤ 0.5 % |
Su | ≤ 0.5 % |
Sulfated ash | ≤ 0.2 % |
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 (*). Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
Corresponds to Ph Eur, BP, NF, FCC, E 200 |