Specifications | |
---|---|
Assay (iodometric, calc. on dried substance) | 99.0 - 101.0 % |
Identity | passes test |
Appearance of solution | passes test |
Chloride (Cl) | ≤ 0.015 % |
Al (Aluminium) | ≤ 0.001 % |
Ca (Calcium) | ≤ 0.005 % |
Cr (Chromium) | ≤ 0.005 % |
Fe (Iron) (*) | ≤ 0.0030 % |
K (Potassium) | ≤ 0.01 % |
Na (Sodium) | ≤ 0.02 % |
Ni (Nickel) (*) | ≤ 0.005 % |
Pb (Lead) | ≤ 0.0080 % |
Zn (Zinc) | ≤ 0.03 % |
Residual solvents (Ph.Eur./ICH) | excluded by manufacturing process |
Loss on drying (250 °C) | ≤ 1.0 % |
* 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, except for the main component. Correspons to Ph Eur, BP |