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Merck Millipore - 1008941000 - Sucralose powder

  • MFR SKU: 1008941000
  • ITEM #: 18508853
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ITEM #: 18508853
EMPROVE® ESSENTIAL Ph Eur, ChP, NF, JPE
This listing is for 1 kg Fibre carton

Merck Millipore - 1008941000 - Sucralose powder

  • Item #: 18508853
  • MFR SKU: 1008941000
  • Catalogue Number 100894
  • CAS number 56038-13-2
  • EC number 259-952-2
  • Grade Ph Eur, ChP, NF, JPE
  • Hill Formula CHClO
  • Molar Mass 397.63 g/mol
  • HS Code 2932 14 00
  • Structure formula Image
  • Quality Level MQ500
  • Density 1.62 g/cm3 (20 ° C) Not applicable
  • Melting Point 114.5 ° C (decomposition)
  • pH value 6 - 8 (100 g/l, HO, 20 ° C)
  • Solubility 300 g/l
  • LD 50 oral LD50 Rat > 10000 mg/kg
  • RTECS LW5440140
  • Storage class 10 - 13 Other liquids and solids
  • WGK WGK 2 obviously hazardous to water
  • Disposal 3
  • Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
  • Storage Store at +15° C to +25° C.
  • Declaration (railroad and road) ADR, RID Kein Gefahrgut
  • Declaration (transport by air) IATA-DGR UN 1845 , 9,
  • Declaration (transport by sea) IMDG-Code UN 1845 , 9,
  • Assay (HPLC, calc. on anhydrous substance) 98.0 - 102.0 %
  • Assay (HPLC, calc. on anhydrous substance) (ChP) 98.0 - 102.0 %
  • Assay (calc. on anhydrous substance) (JPE) 98.0 - 102.0 %
  • Appearance of substance (description) balled powder
  • Appearance of substance (color) almost white
  • Identity (HPLC) conforms
  • Identity (TLC) conforms
  • Identity (IR) conforms
  • Identity (Spec. rotation (Ph Eur)) conforms
  • Spec. Rotation [α² 0/D (calc. on anhydrous substance) (Ph Eur/JPE) +84.0 - +87.5 °
  • Spec. Rotation [α² 0/D (calc. on anhydrous substance) (NF/ChP) +84.0 - +87.5 °
  • Appearance of solution (10 %, water) conforms
  • pH-Test Decrease of 1 pH unit max.
  • Heavy metals (as Pb) ≤ 0.0010 %
  • Methanol ≤ 0.1 %
  • Methanol (ChP) ≤ 0.1 %
  • Cyclohexane ≤ 3880 ppm
  • N, N-Dimethylformamide ≤ 880 ppm
  • Acetic acid ≤ 5000 ppm
  • Ethyl acetate ≤ 5000 ppm
  • Other residual solvents (ICH Q3C) excluded by production process
  • Hydrolysis products ≤ 0.1 %
  • Impurities H and I ≤ 0.1 %
  • Monosaccharide-Chloride (as Fructose) ≤ 0.16 %
  • Related substances (Ph Eur/ChP) ≤ 0.5 %
  • Related substances (NF) ≤ 0.5 %
  • Other Disaccharide-Chlorides ≤ 0.5 %
  • Triphenylphosphine oxide ≤ 150 ppm
  • Residue on ignition ≤ 0.7 %
  • Water (according to Karl Fischer) ≤ 2.0 %
  • Particle Size (d90) ≤ 12 µm
  • Microbiological purity (Total aerobic microbial count (TAMC)) ≤ 1E+03 CFU/g
  • Microbiological purity (Total yeast and mould count (TYMC)) ≤ 1E+02 CFU/g
  • Bile tolerant Gram negative Bacteria (absent in 1 g) conforms
  • Escherichia coli (absent in 1 g) conforms
  • Pseudomonas aeruginosa (absent in 1 g) conforms
  • Staphylococcus aureus (absent in 1 g) conforms
  • Candida albicans (absent in 1 g) conforms
  • Salmonella ssp (absent in 10 g) conforms
  • 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, NF, JPE

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