Specifications | |
---|---|
Assay (complexometric) | 98.0 - 102.0 % |
Assay (complexometric; calculated on dried substance) | ≥ 99.0 % |
Identity | passes test |
Acidity or alkalinity | passes test |
Chloride (Cl) | ≤ 0.0300 % |
Fluoride (F) | ≤ 0.0030 % |
Heavy metals (as Pb) | ≤ 0.001 % |
As (Arsenic) | ≤ 0.0003 % |
Fe (Iron) | ≤ 0.002 % |
Hg (Mercury) | ≤ 0.0001 % |
Na (Sodium) | ≤ 0.2 % |
Pb (Lead) | ≤ 0.0002 % |
Se (Selenium) | ≤ 0.0030 % |
Sr (Strontium) | ≤ 0.05 % |
Zn (Zinc) (*) | ≤ 0.002 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Loss on ignition (800 °C) | 18.0 - 22.0 % |
Loss on drying (250 °C) | ≤ 23.0 % |
* specified acc. to EMEA/CHMP/SWP/4446/2000.Other residues of metal catalysts or metal reagents acc. to this guideline are not likely to be present. | |
Corresponds to Ph Eur,BP,E 516 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |