ال سیستئین هیدروکلراید منوهیدرات کد 102735 مرک آلمان





L(+)-Cysteine hydrochloride monohydrate




Analysis Note

Assay (alkalimetric, calculated on dried substance): 98.5 - 101.0 %
Identity (IR-spectrum): passes test
Identity (Chloride): passes test
Appearance: white to almost white crystalline powder or colorless crystals
Appearance of solution (25 g/l, water): clear and not more intense in color than reference solution BY₆
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance): +5.5 to +7.0
Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance): +5.7 to +6.8
Sulfate (SO₄): ≤ 300 ppm
Heavy metals (as Pb): ≤ 10 ppm
Fe (Iron): ≤ 20 ppm
Related 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 proces
Sulfated ash (600 °C): ≤ 0.1 %
Loss on drying (Vacuum < 0.7 kPa, P₂O₅, 24 h): 8.0 - 12.0 %
Bacterial endotoxins: ≤ 6.0 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., USP.