Assay (acidimetric) | 98.0 - 100.5 % |
Assay (acidimetric, calc. on anhydrous substance) | 99.0 - 101.0 % |
Özdeşlik (IR-spectrum) | conforms |
Appearance | Clear, colorless or pale yellow liquid. |
Appearance of solution (Ph Eur) | conforms |
Refractive index (n 20/D) | 1.453 - 1.459 |
Yoğunluk (d 20/4) | 1.014 - 1.017 g/cm³ |
Relative Yoğunluk (d 20/20) | 1.016 - 1.019 |
Specific gravity (d 25/25) | 1.013 - 1.016 |
Weight per mL | 1.014 - 1.023 g |
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 % |
Related substances (GC) (Unspecified impurities) (Ph Eur) | ≤ 0.10 % |
Related substances (GC) (Total) (Ph Eur) | ≤ 0.3 % |
Residual solvents (ICH Q3C) | ...excluded by production process |
Residue on ignition (600 °C) | ≤ 0.1 |
Su (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 (*). |
Min. shelf life: see product label |