| Assay (acidimetric) |
98.0 - 100.5 % |
| Identity (IR-spectrum) |
conforms |
| Appearance |
Clear, colorless or pale yellow liquid. |
| Refractive index (n 20/D) |
1.453 - 1.459 |
| Density (d 20/4) |
1.014 - 1.017 g/cm³ |
| Specific gravity (d 25/25) |
1.013 - 1.016 |
| Weight per mL |
Weight per mL |
| Distilling range (167 °C - 173 °C) |
≥ 95 |
| Heavy metals (as Pb) |
≤ 0.001 % |
| Fe (Iron) |
≤ 0.00001 % |
| Related substances (GC) (Diethanolamine) |
≤ 0.5 % |
| Related substances (GC) (Triethanolamine) |
≤ 0.5 % |
| Related substances (GC) (any other impurity) |
≤ 0.5 % |
| Related substances (GC) (Sum of all impurities) |
≤ 2.0 % |
| Residual solvents (ICH Q3C) |
...excluded by production process |
| Residue on ignition (600 °C) |
≤ 0.1 |
| Water (according to Karl Fischer) |
≤ 0.25 % |
| 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 (*). |
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