Specifications | |
---|---|
Assay (complexometric) | 99.0 - 102.0 % |
Identity | passes test |
Appearance of solution | passes test |
Free acid | passes test |
pH-value (5 %; water) | 4.4 - 5.6 |
Chloride (Cl) | ≤ 0.0005 % |
Heavy metals (as Pb) | ≤ 0.0010 % |
As (Arsenic) | ≤ 0.0002 % |
Ca (Calcium) | ≤ 0.005 % |
Cd (Cadmium) | ≤ 0.0002 % |
Cu (Copper) | ≤ 0.001 % |
Fe (Iron) | ≤ 0.001 % |
Hg (Mercury) | ≤ 0.0005 % |
Mg (Magnesium) | ≤ 0.005 % |
Pb (Lead) | ≤ 0.0004 % |
Se (Selenium) | ≤ 0.003 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Alkali- and alkaline earth metals (as sulphates) | ≤ 0.5 % |
Loss on Drying (105°C) | 35.5 - 38.5 % |
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present, except for the main component. | |
Corresponds to Ph Eur,BP,JP,USP,FCC |