Identity |
passes test |
Appearance |
clear, viscous, colourless or almost colourless hygroscopic liquid |
Appearance of solution |
passes test |
Acidity,Alkalinity |
passes test |
Reducing substances |
passes test |
Density (d 20/20) |
about 1.080 (50% solution) |
Solidification point |
15 - 25 °C |
Viscosity (20 °C) |
14.8 - 17.6 mm²/s |
Viskosity (20 °C) |
16.0 - 19.0 mPa∙s |
Formaldehyde |
≤ 30 ppm |
Ethylene glycol and diethylene glycol |
≤ 0.4 % |
Ethylene oxide (GC) |
≤ 1 ppm |
Dioxane (GC) |
≤ 10 ppm |
Hydroxyl value |
178 - 197 |
Average molecular mass |
570 - 630 |
Sulfated ash |
≤ 0.2 % |
Water (K. F.) |
≤ 2.0 % |
Other residual solvents acc. to ICH-guideline are excluded by the manufacturing process.Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are notlikely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).Corresponds to Ph Eur |
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