1 | Appearance | Clear, viscous, colorless,very hygroscopic. | Clear, viscous, colorless or slightly yellow liquid,very hygroscopic. |
2 | Solubility | Passes | Miscible with water and with ethanol (96%), soluble in methylene chloride. |
3 | Identification A ( By Relative density) | 1.125 | 1.120-1.130 |
4 | Identification B (By Refractive index) | 1.483 | 1.482-1.485 |
5 | Identification C (By Chromatography) | Complies | The principal peak in the chromatogram obtained with the test solution should similar in retention time and size to the principal peak in the chromatogram obtained with reference solution |
6 | Identification D (By Chemical test) | Complies | The blue color should remain unchanged |
7 | Appearance of Solution | Passes | The solution should be clear and not more intensely colored than reference solution B6. |
8 | Related substances: Impurity A (Ethanolamine) | Not detected | 0.1% max |
9 | Related substances: Impurity B (Diethanolamine) | Not detected | 0.5% max |
10 | Related substances: Impurity C (N-nitrosodiethanolamine) | Not detected | 24 ppb max |
11 | Related substances: Total impurity | 0.9% | 1.0% max |
12 | Water | 0.06% | 1.0% max |
13 | Sulfated ash | 0.04% | 0.1% max |
14 | Assay (anhydrous substance) | 99.8% | 99.0%-103.0% m/m |