| Appearance |
white or yellowish-white pastillic pieces |
| Dropping point |
61 - 66 °C |
| Acid value |
17.0 - 24.0 |
| Saponification value |
87 - 104 |
| Ester value |
70 - 80 |
| Al (Aluminium) |
≤ 10 ppm |
| Ceresin,paraffins and other waxes |
conforms |
| Glycerol and other polyols |
≤ 0.5 % |
| 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 Ph Eur, BP |
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