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L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT BP, Ph. Eur., JP, extra pure suitable for use as excipient, SAFC®
L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT BP, Ph. Eur., JP, extra pure suitable for use as excipient, SAFC®
Catalog # MERP1.04354.0500
CAS Number:  
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L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT BP, Ph. Eur., JP, extra pure suitable for use as excipient, SAFC®
Catalog # MERP1.04354.0500
CAS Number:  

Specifications

  • Pack type:
    Plastic bottle for solids
  • Pk:
    500 g
  • Seq:
    3645
  • Environmentally Preferable:

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

Synonyms: L-Histidine monohydrochloride monohydrate, (2S)-(+)-Histidine monohydrochloride monohydrate, L-Histidine hydrochloride monohydrate, (S)-(+)-Histidine monohydrochloride monohydrate, His HCl monohydrate, H-His-OH.HCl.H2O, H-His-OH·HCl·H₂O, L-3-Imidazol-4-ylalanine monohydrochloride monohydrate, L-Histidine hydrochloride hydrate
 :
 :209.63 g/mol
Merck Index:13,04741
Melting Pt:259 °C (dec.)
Density:1.4723 g/cm³ (20 °C)
Storage Temperature:Ambient
EINECS:211-438-9
CAS Number:5934-29-2
Formula:C₆H₉N₃O₂·HCl·H₂O
MDL Number:MFCD00151027