| Assay (GC, calc. on anhydrous substance) |
≥ 99.5 % |
| Assay (alkalimetric, calculated on anhydrous substance) |
98.0 - 101.0 % |
| Identity |
passes test |
| Color |
≤ 10 APHA |
| Appearance of solution |
passes test |
| Acidity or alkalinity |
passes test |
| Free acid (CH₃COOH) |
≤ 0.002 % |
| Neutrality |
passes test |
| Refractive index (n 20/D) |
1.470 - 1.475 |
| Chloride (Cl) |
≤ 0.0010 % |
| Sulfate (SO₄) |
≤ 0.001 % |
| halogenated compounds (as Cl) |
≤ 0.003 % |
| Heavy metals (as Pb) |
≤ 0.0002 % |
| Al (Aluminium) |
≤ 0.00005 % |
| B (Boron) |
≤ 0.000002 % |
| Ba (Barium) |
≤ 0.00001 % |
| Ca (Calcium) |
≤ 0.0001 % |
| Cd (Cadmium) |
≤ 0.000005 % |
| Co (Cobalt) |
≤ 0.000005 % |
| Cr (Chromium) |
≤ 0.000002 % |
| Cu (Copper) |
≤ 0.000005 % |
| Fe (Iron) |
≤ 0.00001 % |
| Mg (Magnesium) |
≤ 0.0001 % |
| Mn (Manganese) |
≤ 0.00001 % |
| Ni (Nickel) |
≤ 0.000002 % |
| Pb (Lead) |
≤ 0.00001 % |
| Sn (Tin) |
≤ 0.00001 % |
| Zn (Zinc) |
≤ 0.00001 % |
| Acetone |
≤ 0.5 % |
| Other residual solvents (ICH Q3C) |
...excluded by production process |
| Acrolein, glucose and ammonium compounds |
passes test |
| Aldehydes |
≤ 10 ppm |
| Diethylene glycol and related Substances (impurity A) |
≤ 0.1 % |
| Diethylene glycol and related Substances (any further impurity) |
≤ 0.1 % |
| Diethylene glycol and related Substances (Sum of all impurities) |
≤ 0.5 % |
| Fatty acids and esters (as Butyric acid) |
≤ 0.05 % |
| Substances darkened by sulfuric acid |
passes test |
| Sugar |
passes test |
| Sulfated ash |
≤ 0.005 % |
| Water |
≤ 0.5 % |
