| Assay (acidimetric) |
99.0 - 100.5 % |
| Assay (HPLC) |
99.0 - 100.5 % |
| Identity |
conforms |
| Appearance of solution (5 %; water) |
conforms |
| In water insoluble matter |
≤ 0.01 % |
| Melting range (lower value) |
≥ 185.0 °C |
| Melting range (upper value) |
≤ 190.0 °C |
| Melting point |
185.0 - 190.0 °C |
| Chloride (Cl) |
≤ 0.001 % |
| Phosphate (PO₄) |
≤ 0.001 % |
| Sulfate (SO₄) |
≤ 0.003 % |
| Heavy metals (as Pb) |
≤ 0.0020 % |
| Heavy metals (as Pb) (ACS) |
≤ 5 ppm |
| Nitrogen compounds (as N) |
≤ 0.001 % |
| Fe (Iron) |
≤ 5 ppm |
| As (Arsenic) |
≤ 0.0002 % |
| Substances reducing permanganate |
conforms |
| Residual solvents (ICH Q3C) |
excluded by production process |
| Sulfated ash (600 °C) |
≤ 0.02 % |
| 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 NF, JPE, ACS |
|
