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 (*). |
Corresponds to Ph Eur, BP, JP, USP, E260
Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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