| Assay (alkalimetric, calculated on anhydrous substance) |
99.0 - 101.0 % |
| Assay (GC, calc. on anhydrous substance) |
99.0 - 100.5 % |
| Identity (IR-spectrum) |
passes test |
| Identity (GC) |
passes test |
| Identity (precipitate (JPE)) |
passes test |
| Identity (Citrate (JPE)) |
passes test |
| Appearance |
clear solution, not more intense in color than matching fluid A (1:10) and reference solution BY₆ |
| Acidity |
passes test |
| Refractive index (n 20/D) |
1.440 - 1.446 |
| Refractive index (n 25/D) |
1.439 - 1.441 |
| Density (d 25/25) |
1.135 - 1.139 |
| Density (d 20/20) |
1.135 - 1.145 |
| Viscosity (20 °C) |
26 - 38 mPa∙s |
| Sulfate (SO₄) |
≤ 150 ppm |
| Heavy metals (as Pb) |
≤ 5 ppm |
| As (Arsenic) |
≤ 2 ppm |
| Residual solvents (ICH Q3C)class 2 (Cyclohexane) |
≤ 3880 ppm |
| Residual solvents (ICH Q3C) class 3 (Ethanol) |
≤ 5000 ppm |
| Other residual solvents (ICH (Q3C)) |
excluded by manufacturing process |
| Related substances (GC; Ph Eur) (largest single impurity) |
≤ 0.2 % |
| Related substances (GC; Ph Eur) (Sum of all impurities) |
≤ 0.5 % |
| Related substances (GC; JPE) |
passes test |
| Sulfated ash (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 (*). |
|
| Corresponds to Ph. Eur., JPE, NF |
|
