| Assay (Mg; calculated on dried substance) |
4.0 - 5.0 % |
| Identity |
passes test |
| Palmitic- stearic acid components of fatty acids |
≥ 95 % |
| Stearic acid component of fatty acids |
60 - 70 % |
| Acidity or alkalinity |
passes test |
| Chloride (Cl) |
≤ 0.10 % |
| Sulfate (SO₄) |
≤ 0.3 % |
| Heavy metals (as Pb) |
≤ 0.0020 % |
| Al (Aluminium) |
≤ 50 ppm |
| Cd (Cadmium) |
≤ 0.2 ppm |
| Fe (Iron) |
≤ 100 ppm |
| Mn (Manganese) |
≤ 25 ppm |
| Ni (Nickel)* |
≤ 2 ppm |
| Pb (Lead) |
≤ 0.5 ppm |
| V (Vanadium)* |
≤ 2 ppm |
| Zn (Zinc) |
≤ 20 ppm |
| Residual solvents (Ph Eur/USP/ICH) |
excluded by the production process |
| Acid value |
195 - 210 |
| Loss on Drying (105°C) |
≤ 4.0 % |
| Particle Size (d10) |
≥ 1 µm |
| Particle Size (d50) |
about 5 |
| Particle Size (d90) |
≤ 20 µm |
| Specific surface area (BET) |
5 - 12 m²/g |
| Microbiological purity (Total aerobic microbial count (TAMC)) |
≤ 1E+03 CFU/g |
| Microbiological purity (Total yeast and mould count (TYMC)) |
≤ 1E+02 CFU/g |
| Gram negative Bacteria (absent in 1 g) |
passes test |
| Escherichia coli (absent in 1 g) |
passes test |
| Pseudomonas aeruginosa (absent in 1 g) |
passes test |
| Staphylococcus aureus (absent in 1 g) |
passes test |
| Candida albicans (absent in 1 g) |
passes test |
| Salmonella ssp (absent in 10 g) |
passes test |
| 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, JP, NF, FCC |
|
