Analysis Note

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 (wet chemistry): passes test
Identity (Refractive index): 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 (SOâ‚„): ≤ 150 ppm
Heavy metals (as Pb): ≤ 5 ppm
As (Arsenic): ≤ 2 ppm
Cyclohexane (HS-GC): ≤ 3880 ppm
Ethanol (HS-GC): ≤ 5000 ppm
Other residual solvents (ICH (Q3C)): excluded by manufacturing process
Related substances (GC) (largest single impurity): ≤ 0.2 %
Related substances (GC) (Sum of all impurities): ≤ 0.5 %
Triethyl aconitate (GC): ≤ 0.2 %
Related substances (GC): 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

Properties