Stearic acid (GC) | 40.0 - 60.0 % |
Assay (Stearic acid and palmitinic acid) (GC) | ≥ 90.0 % |
Özdeşlik (IR) | Testi geçer |
Özdeşlik (Solidification point) | Testi geçer |
Özdeşlik (acid value) | Testi geçer |
Özdeşlik (GC) | Testi geçer |
Appearance of melt (Ph Eur, BP) | Testi geçer |
Renk of solution (NF) | Testi geçer |
Asitlik | Testi geçer |
Solidification point | 53 - 59 °C |
Heavy metals (as Pb) | ≤ 20 ppm |
Ni (Nickel)* | ≤ 1 ppm |
Residual solvents (ICH Q3C) | excluded by production process |
Iodine number | ≤ 4.0 |
Acid value | 194 - 212 |
Sulfated ash | ≤ 0.1 % |
Particle Size (d10) | ≥ 5 µm |
Particle Size (d50) | 15 - 45 µm |
Particle Size (d90) | ≤ 200 µm |
Specific surface area (BET, volumetric) | 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 |
Bile tolerant 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 |