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L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT Ph. Eur., BP, JP, ChP suitable for use as excipient, SAFC®
L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT Ph. Eur., BP, JP, ChP suitable for use as excipient, SAFC®
Catalog # CA1.04354.0500
CAS Number:  
L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT Ph. Eur., BP, JP, ChP suitable for use as excipient, SAFC®
Catalog # CA1.04354.0500
Supplier Number:  1.04354.0500
CAS Number:  

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Specifications

  • Pack type:
    Plastic bottle
  • Size:
    500 g
  • Cat. no.:
    CA1.04354.0500
  • Supplier No.:
    1.04354.0500

Specifications

Specification Test Results

  • Assay (alkalimetric, calculated on dried substance):
    98.5 - 101.0 %
  • Assay (Perchloric acid titration, calc. on anhydrous substance):
    99.0 - 101.0 %
  • Identity (IR-spectrum):
    passes test
  • Identity (Chloride):
    passes test
  • Appearance:
    white to almost white crystalline powder or colorless crystals
  • Appearance of solution (50 g/l CO₂-free water):
    clear and not more intense in color than reference solution BY₆
  • Appearance of solution (100 g/l, CO₂-free water):
    clear and colorless
  • pH (50 g/l CO₂-free water):
    3.0 - 5.0
  • pH (100 g/l, CO₂-free water):
    3.5 - 4.5
  • Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance):
    +9.2 to +10.6
  • Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on anhydrous substance):
    +9.2 to +10.6
  • Sulfate (SO₄):
    ≤ 200 ppm
  • Heavy metals (as Pb):
    ≤ 10 ppm
  • Fe (Iron):
    ≤ 10 ppm
  • 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 (150 °C):
    7.0 - 10.0 %
  • Water (according to Karl Fischer):
    7.2 - 10.0 %
  • Bacterial endotoxins:
    ≤ 20 I.U./g
  • Microbiological test (total aerobic microbial count (TAMC)):
    ≤ 10²
  • Microbiological test (total yeast and mould count (TYMC)):
    ≤ 10¹

Specification Test Results

About this item

 :
 :209.63 g/mol
Melting Pt:259 °C (dec.)
Density:1.4723 g/cm³ (20 °C)
EINECS:211-438-9
CAS Number:5934-29-2
Formula:C₆H₉N₃O₂·HCl·H₂O
MDL Number:MFCD00151027