| Assay (perchloric acid titration, calculated on dried substance) |
98.5 - 101.0 % |
| Assay (HPLC) |
98.5 - 101.0 % |
| Identity |
passes test |
| Appearance of solution (1 %; water) |
passes test |
| Acidic substances |
passes test |
| Sulphate (SO₄) |
≤ 0.0500 % |
| Fe (Iron) |
≤ 130 ppm |
| Heavy metals (as Pb) |
≤ 0.001 % |
| Chloroform |
≤ 60 ppm |
| Related substances (HPLC, EP) (Highest single impurity) |
≤ 0.10 % |
| Related substances (HPLC, EP) (Sum of all impurities) |
≤ 0.10 % |
| Chromatographic purity (USP) (Highest single impurity) |
≤ 0.1 % |
| Chromatographic purity (USP) (Sum of all impurities) |
≤ 0.1 % |
| Theophylline (HPLC) |
≤ 0.10 % |
| Other residual solvents (ICH Q3C) |
excluded by the manufacturing process |
| Sulfated ash |
≤ 0.1 % |
| Loss on Drying (105°C) |
≤ 0.5 % |
| 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, USP |
|
