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Merck - 1059889050 - D(-)-Mannitol

  • MFR SKU: 1059889050
  • ITEM #: 11569987
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ITEM #: 11569987
fine powder EMPROVE® ESSENTIAL Ph Eur, BP, USP, JP, FCC, E 421
This listing is for 50 kg Drum, fibre

Merck - 1059889050 - D(-)-Mannitol

  • Item #: 11569987
  • MFR SKU: 1059889050
  • Catalogue Number 105988
  • CAS number 69-65-8
  • EC number 200-711-8
  • Grade Ph Eur, BP, USP, JP, FCC, E 421
  • Hill Formula CHO
  • Molar Mass 182.17 g/mol
  • HS Code 2905 43 00
  • Structure formula Image
  • Quality Level MQ500
  • Boiling point 290 - 295 ° C (4 hPa)
  • Density 1.52 g/cm3 (20 ° C)
  • Ignition temperature 410 ° C
  • Melting Point 164 - 169 ° C
  • pH value 5.0 - 6.5 (182 g/l, HO, 25 ° C)
  • Bulk density 400 - 500 kg/m3
  • Solubility 213 g/l
  • LD 50 oral LD50 Rat 13500 mg/kg
  • RTECS OP2060000
  • Storage class 10 - 13 Other liquids and solids
  • WGK WGK 1 slightly 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 +2° C to +25° C.
  • Declaration (railroad and road) ADR, RID Kein Gefahrgut
  • Declaration (transport by air) IATA-DGR No Dangerous Good
  • Declaration (transport by sea) IMDG-Code No Dangerous Good
  • Assay (HPLC, calc. on dried substance) 98.0 - 101.0 %
  • Identity (NIR) passes test
  • Appearance of solution (10%; water) passes test
  • pH-value (10%; water) 4.5 - 7.5
  • Melting point 165 - 169
  • Conductivity (25° C) (20%; water) ≤ 20
  • Heavy metals (as Pb) ≤ 5 ppm
  • Ni (Nickel) (#) ≤ 1 ppm
  • Pb (Lead) ≤ 0.5 ppm
  • Related substances (HPLC) (Sorbitol (Impurity A)) ≤ 2.0 %
  • Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C)) ≤ 2.0
  • Related substances (HPLC) (Major unspecified impurity) ≤ 0.10 %
  • Related substances (HPLC) (Sum of all impurities) ≤ 2.0 %
  • Reducing sugars (as glucose) ≤ 0.05
  • Reducing sugars after hydrolysis/total sugar (as glucose) ≤ 1
  • Sulfated ash ≤ 0.1
  • Water ≤ 0.5 %
  • Loss on Drying (105 ° C) ≤ 0.30 %
  • Particle size (>150µm) ≤ 2 %
  • Residual solvents (ICH Q3C) excluded by manufacturing process
  • Microbiological test passes test
  • Colony count (aerobic bacteria (TAMC)) ≤ 10³
  • Colony count (Yeasts and moulds (TYMC)) ≤ 10²
  • Salmonella spp. in 10g Substance not detectable
  • E.coli in 1g Substance not detectable
  • Staphylococcus aureus in 1g Substance not detectable
  • Pseudomonas aeruginosa in 1g Substance not detectable
  • Candida albicans In 1g Substance not detectable
  • 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., BP, USP, JP, FCC, E 421
  • Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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