| Assay (alkalimetric, calculated on anhydrous substance) |
99.0 - 100.5 % |
| Identity |
passes test |
| Acidity or alkalinity |
passes test |
| Color |
passes test |
| Appearance of solution |
passes test |
| Refractive index (n 20/D) |
1.471 - 1.474 |
| Density (d 20/20) |
≥ 1.258 |
| Density (d 25/25) |
≥ 1.259 |
| Chloride (Cl) |
≤ 0.0010 % |
| Sulfate (SO₄) |
≤ 0.0010 % |
| halogenated compounds (as Cl) |
≤ 0.0030 % |
| Heavy metals (as Pb) |
≤ 0.0005 % |
| As (Arsenic) |
≤ 0.0001 % |
| Ca (Calcium) |
≤ 0.0001 % |
| Calcium (JP) |
passes test |
| Cd (Cadmium) |
≤ 0.0001 % |
| Hg (Mercury) |
≤ 0.0001 % |
| NH₄ (Ammonium) |
passes test |
| Pb (Lead) |
≤ 0.0001 % |
| 1,2,4-Butantriol (GC) |
≤ 0.2 % |
| 3-Monochlorpropan-1,2-diol (3-MCPD) |
≤ 0.1 ppm |
| Acetone |
≤ 0.5 % |
| Other residual solvents (ICH Q3C) |
...excluded by production process |
| 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 % |
| Diethylene glycol and ethylene glycol impurities (diethylene glycol) |
≤ 0.10 % |
| Diethylene glycol and ethylene glycol impurities (ethylene glycol) |
≤ 0.10 % |
| Acrolein, glucose and ammonium compounds |
passes test |
| Acrolein, glucose and other reducing substances |
passes test |
| Aldehydes |
≤ 10 ppm |
| Fatty acids and esters (as Butyric acid) |
≤ 0.05 % |
| Readily carbonizable substances |
passes test |
| Sugar |
passes test |
| Sulfated ash |
≤ 0.01 % |
| Water |
≤ 1.0 % |
| 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, BP, JP, USP, E 422, FCC. Conforms to the purity criteria on food additives according to the current European Commission Regulation. 3-Monochlorpropan-1,2-diol (3-MCPD) test performed by a qualified external laboratory. |
|