Specifications | |
---|---|
Assay (complexometric) | 99.0 - 101.0 % |
Identity | passes test |
Appearance of solution | passes test |
Insoluble matter | ≤ 0.005 % |
Acidity or alkalinity | passes test |
pH-value (5 %; water) | 5.0 - 7.0 |
Bromide (Br) | ≤ 0.05 % |
Sulphate (SO₄) | ≤ 0.005 % |
Heavy metals (as Pb) | ≤ 0.001 % |
Al (Aluminium) | ≤ 0.0001 % |
As (Arsenic) | ≤ 0.0002 % |
Ba (Barium) | passes test |
Ca (Calcium) | ≤ 0.01 % |
Fe (Iron) | ≤ 0.0005 % |
Hg (Mercury) | ≤ 0.0001 % |
K (Potassium) | ≤ 0.0500 % |
NH₄ (Ammonium) | ≤ 0.005 % |
Pb (Lead) | ≤ 0.0002 % |
Residual solvents (Ph.Eur./USP/ICH) | excluded by manufacturing process |
Water | 51.0 - 55.0 % |
Endotoxins | ≤ 3.0 I.U./g |
Total aerobic microbial count | ≤ 100 CFU/g |
Total yeast and mould count | ≤ 100 CFU/g |
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
|
Corresponds to Ph Eur, BP, USP, JPC, FCC, E511 |