| Stearic acid (GC) |
40.0 - 60.0 % |
| Assay (Stearic acid and palmitinic acid) (GC) |
≥ 90.0 % |
| Identity |
passes test |
| Appearance of melt (Ph Eur, BP) |
passes test |
| Color of solution (NF) |
passes test |
| Acidity |
passes test |
| Solidification point |
54 - 59 °C |
| Heavy metals (as Pb) |
≤ 0.0010 % |
| Ni (Nickel)* |
≤ 1 ppm |
| Residual solvents (ICH Q3C) |
excluded by production process |
| Iodine number |
≤ 4.0 |
| Acid value |
194 - 210 |
| Sulfated ash |
≤ 0.10 % |
| Particle Size (d10) |
≥ 5 µm |
| Particle Size (d50) |
about 35 |
| Particle Size (d90) |
≤ 200 µm |
| Specific surface area (BET) |
0.90 - 1.40 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) |
conforms |
| Escherichia coli (absent in 1 g) |
conforms |
| Pseudomonas aeruginosa (absent in 1 g) |
conforms |
| Staphylococcus aureus (absent in 1 g) |
conforms |
| Candida albicans (absent in 1 g) |
conforms |
| Salmonella ssp (absent in 10 g) |
conforms |
| 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 |
|
