| Assay (HPLC) |
98.0 - 102.0 % |
| Assay (ex N) |
99.0 - 100.5 % |
| Assay (ex N, calc. on dried substance) |
99.0 - 101.0 % |
| Identity |
conforms |
| Appearance |
Colorless crystals or white, crystalline powder. |
| Appearance of solution (5 %; water) |
conforms |
| In ethanol (96 %) insoluble parts |
≤ 0.04 % |
| Alkalinity |
passes test |
| Melting point (DSC (differential scanning calorimetry)) |
132.5 - 134.5 °C |
| Chloride (Cl) |
≤ 0.007 % |
| Sulphate (SO₄) |
≤ 0.010 % |
| Heavy metals (as Pb) |
≤ 0.0010 % |
| NH₄ (Ammonium) |
≤ 0.0500 % |
| Biuret |
≤ 0.1 % |
| Organic Impurities (Related compound A) |
≤ 0.1 % |
| Organic Impurities (Any individual unspecified impurity) |
≤ 0.1 % |
| Organic Impurities (Total impurities) |
≤ 2.0 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Sulfated ash (600 °C) |
≤ 0.10 % |
| Loss on Drying (105°C) |
≤ 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 |
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