Analysis Note

Assay (alkalimetric, calculated on dried substance): 98.5 - 101.0 %Identity (IR-spectrum): passes testIdentity (Chloride): passes testAppearance: white or 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, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance): +5.5 to +7.0Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance): +5.7 to +6.8Sulfate (SO₄): ≤ 300 ppmHeavy metals (as Pb): ≤ 10 ppmFe (Iron): ≤ 20 ppmRelated Compounds, total (TLC): ≤ 0.5 %Ninhydrin-positive substances (LC)(impurity A (570 nm)): ≤ 0.5 %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): ≤ 1.0 %Residual solvents (ICH Q3C): excluded by manufacturing processSulfated ash (600 °C): ≤ 0.1 %Loss on drying (Vacuum < 0.7 kPa, P₂O₅, 24 h): 8.0 - 12.0 ºcterial endotoxins: ≤ 6.0 I.U./g

Biochem/physiol Actions

NMDA glutamatergic receptor antagonist.

Packaging

1 kg in Plastic bottle

25, 100 g in Plastic bottle