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103140 Parteck® SI 400 (Sorbitol)

Overview

Replacement Information

Key Spec Table

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

Pricing & Availability

Catalogue Number AvailabilityPackaging Qty/Pack Price Quantity
1031402500
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      Plastic bottle 2.5 kg
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      1031408889
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          Fibre carton 0 kg
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          1031409026
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              Plastic sack 25 kg
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              1031409028
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                  Fibre carton 25 kg
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                  1031409053
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                      Plastic drum 50 kg
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                      1031409400
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                          Big Bag 400 kg
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                          1031409500
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                              Big Bag 500 kg
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                              1031409501
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                                  Big Bag 500 kg
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                                  1031409999
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                                      0 kg
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                                      Description
                                      Catalogue Number103140
                                      SynonymsD-Glucitol
                                      References
                                      Product Information
                                      CAS number50-70-4
                                      EC number200-061-5
                                      GradePh Eur,BP,NF,FCC,JSFA,E 420
                                      Hill FormulaC₆H₁₄O₆
                                      Molar Mass182.17 g/mol
                                      HS Code2905 44 91
                                      Structure formula ImageStructure formula Image
                                      Quality SegmentMQ500
                                      Applications
                                      Biological Information
                                      Physicochemical Information
                                      Density1.49 g/cm3 (20 °C)
                                      Ignition temperature420 °C
                                      Melting Point98 - 100 °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
                                      Dimensions
                                      Materials Information
                                      Toxicological Information
                                      LD 50 oralLD50 Rat 15900 mg/kg
                                      Safety Information according to GHS
                                      RTECSLZ4290000
                                      Safety Information
                                      Product Usage Statements
                                      Storage and Shipping Information
                                      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 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 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≤ 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.
                                      Global Trade ITEM Number
                                      Catalogue Number GTIN
                                      1031402500 04022536961354
                                      1031408889 04027269301866
                                      1031409026 04022536583501
                                      1031409028 04022536936437
                                      1031409053 04054839032981
                                      1031409400 04027269132316
                                      1031409500 04022536531366
                                      1031409501 04022536864600
                                      1031409999 04022536510477

                                      Documentation

                                      Material Qualification Dossier

                                      TitleVersion
                                      10.1

                                      Quality Management Dossier (Open Access)

                                      Title

                                      Operational Excellence Dossier

                                      Title

                                      Parteck® SI 400 (Sorbitol) SDS

                                      Title

                                      Safety Data Sheet (SDS) 

                                      Parteck® SI 400 (Sorbitol) Certificates of Analysis

                                      Product Number PackagingSpecificationLot Number
                                      1031402500 Plastic bottlePDF Specification Document
                                      1031408889 Fibre cartonPDF Specification Document
                                      1031409026 Plastic sackPDF Specification Document
                                      1031409028 Fibre cartonPDF Specification Document
                                      1031409053 Plastic drumPDF Specification Document
                                      1031409400 Big BagPDF Specification Document
                                      1031409500 Big BagPDF Specification Document
                                      1031409501 Big BagPDF Specification Document
                                      1031409999 PDF Specification Document

                                      Certificates

                                      Title