| Assay (cerimetric, calculated on dried substance) |
99.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Substances soluble in water (Hotextract) |
≤ 0.5 % |
| Substances soluble in water (Coldextract) |
≤ 0.25 % |
| Substances soluble in dilute hydrochloric acid |
≤ 0.5 % |
| Acidity or alkalinity |
passes test |
| Aluminium oxide and/or Silicon dioxide |
≤ 2.0 % |
| Heavy metals (as Pb) |
≤ 0.002 % |
| Acid soluble barium (Ba) |
passes test |
| Acid soluble antimony (Sb) |
≤ 0.0002 % |
| As (Arsenic) |
≤ 0.0001 % |
| Cd (Cadmium) |
≤ 0.00005 % |
| Fe (Iron) |
≤ 0.02 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Pb (Lead) |
≤ 0.0010 % |
| Sb (Antimony) |
≤ 0.005 % |
| V(Vanadium)* |
≤ 0.0010 % |
| Zn (Zinc) |
≤ 0.005 % |
| Residual solvents (Ph Eur/USP/ICH) |
excluded by the manufacturing process |
| Microbiological test (Total yeast and mould count (TYMC)) |
≤ 100 CFU/g |
| Microbiological test (Total aerobic microbial count (TAMC)) |
≤ 100 CFU/g |
| Particle Size (d10) |
≥ 0.1 µm |
| Particle Size (d50) |
about 0.8 µm |
| Particle Size (d90) |
≤ 2.5 µm |
| Loss on ignition (800 °C) |
≤ 0.5 % |
| Loss on drying (105 °C; 3 h) |
≤ 0.5 % |
| 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 (*).Conforms to the purity criteria on food additives according to the current European Commission Regulation |
|
| conforms to Ph Eur, BP, USP, JP, E171 |
|
