Specifications | |
---|---|
Assay (complexometric; calculated on dried substance) | 99.0 - 100.5 % |
Identity | passes test |
Appearance of solution | passes test |
pH-value (5 %; water) | 5.0 - 8.2 |
Acidity or alkalinity | conforms |
Chloride (Cl) | ≤ 0.014 % |
Heavy metals (as Pb) | ≤ 0.0005 % |
As (Arsenic) | ≤ 0.0002 % |
Ca (Calcium) | ≤ 0.01 % |
Fe (Iron) | ≤ 0.0010 % |
Se (Selenium) | ≤ 0.001 % |
Zn (Zinc) | passes test |
Loss on drying (450 °C) | 49.0 - 52.0 % |
Residual solvents (ICH Q3C) | Excluded by production process |
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, USP, JP |