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Merck - 1043529010 - L-HISTIDINE SUITABLE FO (10KG) (Each)

  • MFR SKU: 1043529010
  • ITEM #: 7028951
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ITEM #: 7028951
L-histidine suitable for use as excipient EMPROVE exp PH EUR, USP^ 10kg
This listing is for Each

Merck - 1043529010 - L-HISTIDINE SUITABLE FO (10KG) (Each)

  • Item #: 7028951
  • MFR SKU: 1043529010
  • Catalogue Number 104352
  • Synonyms His
  • CAS number 71-00-1
  • EC number 200-745-3
  • Grade Ph Eur, ChP, JP, USP
  • Hill Formula CHNO
  • Molar Mass 155.16 g/mol
  • HS Code 2933 29 90
  • Structure formula Image
  • Quality Level MQ500
  • Density 1.449 g/cm3 (20 ° C)
  • Melting Point 285 ° C (decomposition)
  • pH value 7.0 - 8 (15.5 g/l, HO, 25 ° C)
  • Bulk density 430 kg/m3
  • Solubility 38.2 g/l
  • LD 50 oral LD50 Rat > 5110 mg/kg
  • RTECS MS3070000
  • Storage class 10 - 13 Other liquids and solids
  • WGK WGK 1 slightly hazardous to water
  • Storage Store at +2° C to +30° C.
  • 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
  • Identity (specific rotation) passes test
  • Identity (TLC) 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 BY.
  • Appearance of solution (20g/l, water) clear and colorless
  • Transmittance of solution (30 g/l, water) ≥ 98.0 %
  • Spec. rotation (α 20/D, 110g/l, hydrochloric acid 120g/l, calc. on dried substance) +11.4 to +12.4
  • Spec. rotation (α 25/D, 110g/l, hydrochloric acid 6mol/l, calc. on dried substance) +12.6 to +14.0
  • Spec. rotation (α 20/D, 110g/l, hydrochloric acid6mol/l, calc. on dried substance) +12.0 to +12.8
  • pH (20g/l, CO-free water) 7.0 - 8.5
  • Acidity (20g/l, water) 7.0 - 8.5
  • Chloride (Cl) ≤ 200 ppm
  • Sulfate (SO) ≤ 200 ppm
  • Heavy metals (as Pb) ≤ 10 ppm
  • As (Arsenic) ≤ 1 ppm
  • Cu(Copper) ≤ 25 ppm
  • Fe (Iron) ≤ 10 ppm
  • Mn (Manganese) ≤ 25 ppm
  • Zn (Zinc) ≤ 130 ppm
  • Other amino acids (TLC) ≤ 0.5 %
  • 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; 3h) ≤ 0.2 %
  • Bacterial endotoxins < 2.0
  • Bacterial endotoxins (ChP) < 6.0
  • Microbiological test (total aerobic microbial count (TAMC)) ≤ 10²
  • Microbiological test (total yeast and mould count (TYMC)) ≤ 10²
  • 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., ChP, JP, USP

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