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103140 Parteck® SI 400 (Sorbitol)


Replacement Information

Key Specifications Table

CAS #EC NumberHill FormulaMolar MassGrade Value
50-70-4 200-061-5 C₆H₁₄O₆ 182.17 g/mol Ph Eur,BP,JSFA,NF,E 420

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      Catalogue Number103140
      Product Information
      CAS number50-70-4
      EC number200-061-5
      GradePh Eur,BP,JSFA,NF,E 420
      Hill FormulaC₆H₁₄O₆
      Molar Mass182.17 g/mol
      HS Code2905 44 91
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Biological Information
      Physicochemical Information
      Density1.49 g/cm3 (20 °C)
      Flash point>100 °C
      Ignition temperature420 °C
      Melting Point94 - 96 °C
      pH value6 - 7 (100 g/l, H₂O, 20 °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
      WGKNWG not water endangering
      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
      Assay (HPLC, calc.on anhydrous substance)97.0 - 100.5 %
      Identitypasses test
      pH-value (10 %; water)3.5 - 7.0
      Free acidpasses test
      Appearance of solution (10 %; 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)≤ 0.010 %
      Heavy metals as Pb≤ 5 ppm
      As (Arsenic)≤ 1 ppm
      Ni (Nickel) (#)≤ 1 ppm
      Pb (Lead)≤ 0.5 ppm
      Ru (Ruthenium) (#)≤ 1 ppm
      Related substances (HPLC, Ph.Eur) (Major impurities)≤ 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≤ 3.0
      Water≤ 1.5 %
      Particle size (< 212 µm)≤ 10 %
      Particle size (> 850 µm)≤ 10 %
      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 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 an indicated (#).
      Corresponds to Ph. Eur., BP, JSFA, NF, E 420
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.


      Material Qualification Dossier

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      Quality Management Dossier


      Operational Excellence Dossier


      Parteck® SI 400 (Sorbitol) SDS


      Safety Data Sheet (SDS) 

      Parteck® SI 400 (Sorbitol) Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1031409500 Big BagPDF Specification Document




      MultiPharmTM Minerals for Solid Dosage Forms