Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %Identity (IR-spectrum)passes testIdentity (specific rotation)passes testAppearancewhite to almost white crystalline powder or colorless crystalsAppearance of solution (25 g/l, water)clear and not more intense in color than reference solution BY₆Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 250 g/l, calc. on dried substance)+13.5 to +15.5Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 100 ppmAs (Arsenic)≤ 5 ppmCa (Calcium)≤ 50 ppmCo (Cobalt)≤ 5 ppmFe (Iron)≤ 5 ppmK (Potassium)≤ 5 ppmMg (Magnesium)≤ 5 ppmNa (Sodium)≤ 50 ppmPb (Lead)≤ 10 ppmZn (Zinc)≤ 5 ppmNinhydrin-positive substances (LC)(any ninhydrin-positive impurity)≤ 0.1 %Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %Ninhydrin-positive substances (LC)(total impurities)≤ 0.5 %Loss on drying (105 °C; 3 h) ≤ 0.2 %≤ 0.2 %



