ویژگیها | |
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Assay (alkalimetric) | 99.8 - 100.5 % |
Identity | passes test |
Appearance of the substance | passes test |
Solidification temperature | ≥ 15.6 °C |
Foreign organic substances | passes test |
Formic acid, Formates and other oxidable impurities (as HCOOH) | ≤ 0.10 % |
Heavy metals (as Pb) | ≤ 0.0005 % |
Chloride (Cl) | ≤ 0.0002 % |
Sulphate (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) | passes test |
Substances reducing potassium permanganate | passes test |
Evaporation residue | ≤ 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 (*). |
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Corresponds to Ph Eur, BP, JP, USP, E260 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |