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L(+)-Histidine 99.0-101.0% (by perchloric acid titration), EMPROVE® EXPERT Ph. Eur., USP, JP, SAFC®
L(+)-Histidine 99.0-101.0% (by perchloric acid titration), EMPROVE® EXPERT Ph. Eur., USP, JP, SAFC®
Supplier:  MilliporeSigma
Certificates
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L(+)-Histidine 99.0-101.0% (by perchloric acid titration), EMPROVE® EXPERT Ph. Eur., USP, JP, SAFC®
Supplier:  MilliporeSigma
Certificates

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Specification Test Results

  • Assay (Acidimetric, Calculated on Dried Substance):
    98.5 - 101.0%
  • Assay (Perchloric Acid Titration, Calculated on Dried Substance):
    99.0 - 101.0%
  • Identity (IR-spectrum):
    Passes Test
  • Appearance:
    White to Almost White Fine-Crystalline Powder or Colorless Crystals
  • Appearance of Solution (50 g/l; Water):
    Clear and not More Intense in Color than Reference Solution BY₇
  • Appearance of Solution (20 g/l, Water):
    Clear and Colorless
  • Specific Rotation (α 20/D, 110 g/l, Hydrochloric Acid 120 g/l, Calculated on Dried Substance):
    +11.4 to +12.4
  • Specific Rotation (α 25/D, 110 g/l, Hydrochloric Acid 6 mol/l, Calculated on Dried Substance):
    +12.6 to +14.0
  • Specific Rotation (α 20/D, 110 g/l, Hydrochloric Acid 6 mol/l, Calculated on Dried Substance):
    +11.8 to +12.8°
  • pH (20 g/l, CO₂-Free Water):
    7.0 - 8.5
  • Chloride (Cl):
    ≤200 ppm
  • Sulfate (SO₄):
    ≤200 ppm
  • Heavy Metals (as Pb):
    ≤10 ppm
  • Cu (Copper):
    ≤25 ppm
  • Fe (Iron):
    ≤10 ppm
  • Fe (Iron) (ICP):
    ≤10 ppm
  • Mn (Manganese):
    ≤25 ppm
  • Zn (Zinc):
    ≤130 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; 3 h):
    ≤0.2%
  • Bacterial Endotoxins:
    <2.0
  • Microbiological Test (Total Aerobic Microbial Count (TAMC)):
    ≤10²
  • Microbiological Test (Total Yeast and Mould Count (TYMC)):
    ≤10²

Specification Test Results

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