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| Assay (calculated on dried substance) | 99.0 – 101.0 % |
| Assay (calc.on anhydrous substance) | 99.0 – 101.0 % |
| Identity (IR-spectrum) | passes test |
| Identity (pH) | passes test |
| Identity (wet chemistry) | passes test |
| Identity (specific rotation) | passes test |
| Identity (TLC) | passes test |
| Appearance | white to almost white crystalline powder or colorless crystals |
| Appearance of solution (50 g/l CO₂-free water) | clear and not more intense in color than reference solution BY₆ |
| Appearance of solution (100 g/l, CO₂-free water) | clear and colorless |
| Transmittance of solution (100 g/l, water) | ≥ 98.0 % |
| pH (50 g/l CO₂-free water) | 3.0 – 5.0 |
| pH (100 g/l, CO₂-free water) | 3.5 – 4.5 |
| Acidity (100 g/l, water) | 3.5 – 4.5 |
| Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance) | 9.2 to 10.6 |
| Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) | 8.5 to 10.5 |
| Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on anhydrous substance) | 9.2 to 10.6 |
| Chloride (argentometric, calc. on dried substance) | 16.7 – 17.1 % |
| Sulfate (SO₄) | ≤ 200 ppm |
| Heavy metals (as Pb) | ≤ 10 ppm |
| As (Arsenic) | ≤ 1 ppm |
| Fe (Iron) | ≤ 10 ppm |
| Other amino acids (TLC) | ≤ 0.2 % |
| Related substances (TLC) | passes test |
| Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) | ≤ 0.2 % |
| Ninhydrin-positive substances (LC) (ammonium (570 nm)) | ≤ 0.02 % |
| Ninhydrin-positive substances (LC) (total impurities) | ≤ 0.5 % |
| Residual solvents (ICH (Q3C)) | excluded by manufacturing process |
| Sulfated ash (600 °C) | ≤ 0.1 % |
| Loss on drying (150 °C) | 7.0 – 10.0 % |
| Loss on drying (105 °C; 3 h) | ≤ 0.2 % |
| Water (according to Karl Fischer) | 7.2 – 10.0 % |
| Bacterial endotoxins | ≤ 20 I.U./g |
| Bacterial endotoxins (ChP) | < 6.0 |
| Microbiological test (total aerobic microbial count (TAMC)) | ≤ 10² |
| Microbiological test (total yeast and mould count (TYMC)) | ≤ 10¹ |
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