| Assay (Perchloric acid titration, calc. on anhydrous substance) |
99.0 - 101.0 % |
| Identity |
passes test |
| Appearance of solution (20 %; water) |
passes test |
| Colour of solution |
passes test |
| Clarity of solution |
passes test |
| Acidity or alkalinity |
passes test |
| Heavy metals (as Pb) |
≤ 10 ppm |
| Benzoate and Salicylate |
passes test |
| 2-toluene sulfonamide (GC) |
≤ 10 ppm |
| 4-toluene sulfonamide (GC) |
≤ 10 ppm |
| Methanol (HS-GC) |
≤ 3000 ppm |
| Toluene (HS-GC) |
≤ 890 ppm |
| Other residual solvents (ICH Q3C) |
excluded by the production process |
| Readily carbonisable substance |
passes test |
| Water (according to Karl Fischer) |
≤ 15.0 % |
| 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, USP |
|
