| Assay (perchloric acid titration, calculated on dried substance) |
98.5 - 101.0 % |
| Identity (IR-spectrum) |
passes test |
| Appearance |
white to almost white, crystalline powder |
| Appearance of solution (100 g/l, CO₂-free water) |
clear and colorless and not more intense in color than reference solution Y₇ |
| pH (50 g/l CO₂-free water) |
5.9 - 6.4 |
| Chloride (Cl) |
≤ 70 ppm |
| Sulfate (SO₄) |
≤ 65 ppm |
| Heavy metals (as Pb) |
≤ 10 ppm |
| As (Arsenic) |
≤ 2 ppm |
| Hydrolyzable substances |
passes test |
| Related substances (TLC) |
passes test |
| Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) |
≤ 0.10 % |
| Ninhydrin-positive substances (LC) (ammonium (570 nm)) |
≤ 0.02 % |
| Ninhydrin-positive substances (LC) (total impurities) |
≤ 1.0 % |
| Related substances (HPLC) (Impurity B) |
≤ 0.10 % |
| Related substances (HPLC) (Impurity H) |
≤ 0.10 % |
| Related substances (HPLC) (Impurity I) |
≤ 0.10 % |
| Related substances (HPLC) (unspecified impurities) |
≤ 0.10 % |
| Related substances (HPLC) (Sum of all impurities) |
≤ 0.2 % |
| Methanol (HS-GC) |
≤ 3000 ppm |
| Other residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Loss on drying (105 °C, 2 h) |
≤ 0.2 % |
| Sulfated ash (600 °C) |
≤ 0.1 % |
| Bacterial endotoxins |
≤ 3.0 I.U./g |
| 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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