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115079 Parteck® SI 200 (Sorbitol)


Replacement Information

Key Specifications Table

CAS #EC NumberHill FormulaMolar MassGrade Value
50-70-4200-061-5C₆H₁₄O₆182.17 g/molPh Eur,BP,JP,NF,E 420

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      Fibre carton 25 kg
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      Catalogue Number115079
      Product Information
      CAS number50-70-4
      EC number200-061-5
      GradePh Eur,BP,JP,NF,E 420
      Hill FormulaC₆H₁₄O₆
      Molar Mass182.17 g/mol
      HS Code2905 44 91
      Quality LevelMQ500
      Biological Information
      Physicochemical Information
      Density1.49 g/cm3 (20 °C)
      Ignition temperature420 °C
      Melting Point94 - 96 °C
      pH value5.0 - 7 (182 g/l, H₂O, 25 °C)
      Vapor pressure<0.1 hPa (25 °C)
      Bulk density450 kg/m3
      Solubility2350 g/l
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat 15900 mg/kg
      Safety Information according to GHS
      Storage class10 - 13 Other liquids and solids
      WGKWGK 1 slightly hazardous to water
      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
      Supplemental Information
      Assay (HPLC, calc.on anhydrous substance)97.0 - 100.5 %
      Identitypasses test
      pH-value (10 %; water)3.5 - 7.0
      Appearance of solution (25 %; water)passes test
      Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance)4.0 - 7.0 °
      Conductivity (25°C) (20 %; water)≤ 20
      Chloride (Cl)≤ 0.002 %
      Sulfate (SO₄)≤ 0.005 %
      Heavy metals (as Pb)≤ 5 ppm
      As (Arsenic)≤ 1.0 ppm
      Ni (Nickel) (#)≤ 1 ppm
      Pb (Lead)≤ 0.5 ppm
      Ru (Ruthenium) (#)≤ 1 ppm
      Related substances (HPLC, Ph. Eur.) (major impurity)≤ 2.0 %
      Related substances (HPLC, EP) (Sum of all impurities)≤ 3.0 %
      Reducing sugars after hydrolysis/total sugar (as glucose)≤ 0.8
      Reducing sugars (as glucose)≤ 0.11 %
      Sulfated ash≤ 0.02 %
      Loss on drying≤ 2.0 %
      Water≤ 1.5 %
      Particle size (< 100 µm)≤ 15 %
      Particle size (> 200 µm)35 - 70 %
      Particle size (> 500 µm)≤ 6 %
      Residual solvents (ICH Q3C)excluded by manufacturing process
      Microbiological testpasses test
      Colony count (aerobic bacteria (TAMC))≤ 5*10²
      Colony count (Yeasts and moulds (TYMC))≤ 10²
      Salmonella 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, NF, E 420
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.


      Material Qualification Dossier

      TitleLot Number

      Quality Management Dossier


      Operational Excellence Dossier


      Parteck® SI 200 (Sorbitol) SDS


      Safety Data Sheet (SDS) 

      Parteck® SI 200 (Sorbitol) Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1150799025 Fibre cartonPDF Specification Document


      Halal Certificate for 115079 Parteck® SI 200 (Sorbitol) EMPROVE®
      Kosher Certificate 115079 Parteck® SI 200 (Sorbitol) suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,NF,E 420