مشخصات فنی محصول | |
---|---|
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 % |
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 |