Saflık (alkalimetrik) | 99.8 - 100.5 % |
Özdeşlik | Testi geçer |
Appearance of the substance | Testi geçer |
Solidification temperature | ≥ 15.6 °C |
Foreign organic substances | Testi geçer |
Formic acid, Formates and other oxidable impurities (as HCOOH) | ≤ 0.10 % |
Heavy metals (as Pb) | ≤ 0.0005 % |
Chloride (Cl) | ≤ 0.0002 % |
Sulfate (SO₄) | ≤ 0.0005 % |
Al (Aluminium) | ≤ 0.00005 % |
As (Arsenic) | ≤ 0.00010 % |
Cu (Copper) | ≤ 0.0005 % |
Fe (Iron) | ≤ 0.0005 % |
Hg (Mercury) | ≤ 0.00010 % |
Pb (Lead) | ≤ 0.00005 % |
Zn (Zinc) | ≤ 0.0005 % |
Other residual solvents (ICH Q3C) | ...excluded by production process |
Reducing substances (Ph.Eur.) | Testi geçer |
Substances reducing potassium permanganate | Testi geçer |
Buharlaşma Kalıntısı | ≤ 0.005 % |
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, BP, JP, USP, E260 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |