| Assay (GC) |
≥ 90.0 % |
| Identity (GC) |
passes test |
| Appearance |
Clear liquid, not more intense in color than reference solution Y₇ (Ph. Eur.). |
| Refractive index (n 20/D) |
1.434 - 1.436 |
| Density (d 25/25) |
0.846 - 0.854 |
| Viscosity |
5 - 6 mPa∙s |
| Iodine value |
≤ 1.0 |
| Acid value |
≤ 1.0 |
| Saponification value |
202 - 212 |
| Residual solvents (Ph.Eur./USP/ICH) class 2 (Methanol) |
≤ 3000 ppm |
| Residual solvents (Ph. Eur./USP/ICH) class 3 (Propan-2-ol) |
≤ 5000 ppm |
| Other residual solvents (Ph. Eur./USP/ICH) |
excluded by manufacturing process |
| Organic volatile impurities (according to USP) |
conforms |
| Sulfated ash |
≤ 0.1 % |
| Water (according to Karl Fischer) |
≤ 0.1 % |
| 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., NF |
|