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100493 Parteck® M 300 (Mannitol)

EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP,E 421

100493
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1004939025
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      		 Fibre carton 25 kg
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      Description
      Catalogue Number100493
      References
      Product Information
      CAS number69-65-8
      EC number200-711-8
      GradePh Eur,BP,JP,USP,E 421
      Hill FormulaC₆H₁₄O₆
      Molar Mass182.17 g/mol
      HS Code2905 43 00
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Boiling point290 - 295 °C (4 hPa)
      Density1.52 g/cm3 (20 °C)
      Ignition temperature410 °C
      Melting Point166 - 168 °C
      pH value5.0 - 6.5 (182 g/l, H₂O, 25 °C)
      Bulk density400 - 500 kg/m3
      Solubility213 g/l
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat 13500 mg/kg
      Safety Information according to GHS
      RTECSOP2060000
      Storage class10 - 13 Other liquids and solids
      WGKWGK 2 obviously hazardous to water
      Disposal3
      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.
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      StorageStore at +2°C to +25°C.
      Packaging Information
      Transport Information
      Declaration (railroad and road) ADR, RIDKein Gefahrgut
      Declaration (transport by air) IATA-DGRNo Dangerous Good
      Declaration (transport by sea) IMDG-CodeNo Dangerous Good
      Supplemental Information
      Specifications
      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 point165 - 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 (< 53 µm)≤ 10 %
      Particle size (> 500 µm)≤ 15 %
      Residual solvents (ICH Q3C)excluded by manufacturing process
      Microbiological testpasses test
      Colony count (aerobic bacteria (TAMC))≤ 10³
      Colony count (Yeasts and moulds (TYMC))≤ 10²
      Salmonella spp.in 10g Substance not detectable
      E.coliin 1g Substance not detectable
      Staphylococcus aureusin 1g Substance not detectable
      Pseudomonas aeruginosain 1g Substance not detectable
      Candida albicansIn 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, JP, USP, E421
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.
      Global Trade Item Number
      Catalogue Number GTIN
      1004939025 04027269341961

      Documentation

      Parteck® M 300 (Mannitol) SDS

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      Safety Data Sheet (SDS) 

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