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L-Arginine hydrochloride 98.5-101.0% (by perchloric acid titration), EMPROVE® EXPERT Ph. Eur., BP, JP, USP suitable for use as excipient, SAFC®
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L-Arginine hydrochloride 98.5-101.0% (by perchloric acid titration), EMPROVE® EXPERT Ph. Eur., BP, JP, USP suitable for use as excipient, SAFC®
New Product
 

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  • Assay (perchloric acid titration, calculated on dried substance):
    98.5 - 101.0 %
  • Identity (IR-spectrum):
    passes test
  • Identity (Chloride):
    passes test
  • Appearance:
    white to almost white or colorless, irregular crystals
  • Appearance of solution (50 g/l; water):
    clear and not more intense in color than reference solution BY₆
  • Appearance of solution (100 g/l, water):
    clear and colorless
  • pH (100 g/l, CO₂-free water):
    4.7 - 6.2
  • Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance):
    +21.0 to +23.5
  • Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance):
    +21.4 to +23.6
  • Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l,previously dried substance):
    +21,5 to +23,5
  • Chloride (Cl) (argentometric):
    16.5 - 17.1 %
  • Sulfate (SO₄):
    ≤ 200 ppm
  • Heavy metals (as Pb):
    ≤ 10 ppm
  • As (Arsenic):
    ≤ 2 ppm
  • Fe (Iron):
    ≤ 10 ppm
  • NH₄ (Ammonium):
    ≤ 200 ppm
  • Related Compounds, total (TLC):
    ≤ 0.5 %
  • 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 (105 °C, 2 h):
    ≤ 0.2 %
  • Bacterial endotoxins:
    ≤ 3.0 I.U./g

 

 

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