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103140 Parteck® SI 400 (Sorbitol)

Overview

Replacement Information

Key Specifications Table

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

Pricing & Availability

Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
1.03140.2503
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      Plastic bottle 2.5 kg
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      1.03140.9027
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          Fibre carton 25 kg
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          1.03140.9050
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              Fibre carton 50 kg
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              1031409051
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                  Plastic drum 50 kg
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                  1031409053
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                      Plastic drum 50 kg
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                      1031409100
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                          Plastic drum 100 kg
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                          1031409424
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                              Big Bag 424 kg
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                              1031409500
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                                  Big Bag 500 kg
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                                  Description
                                  Catalogue Number103140
                                  SynonymsD-Glucitol
                                  References
                                  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
                                  Applications
                                  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
                                  Dimensions
                                  Materials Information
                                  Toxicological Information
                                  LD 50 oralLD50 Rat 15900 mg/kg
                                  Safety Information according to GHS
                                  RTECSLZ4290000
                                  Storage class10 - 13 Other liquids and solids
                                  WGKWGK 1 slightly 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 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.

                                  Documentation

                                  Material Qualification Dossier

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                                  2.0

                                  Quality Management Dossier

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                                  Operational Excellence Dossier

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                                  Parteck® SI 400 (Sorbitol) SDS

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                                  Safety Data Sheet (SDS) 

                                  Parteck® SI 400 (Sorbitol) Certificates of Analysis

                                  Product Number PackagingSpecificationLot Number
                                  1.03140.2503 Plastic bottlePDF Specification Document
                                  1.03140.9027 Fibre cartonPDF Specification Document
                                  1.03140.9050 Fibre cartonPDF Specification Document
                                  1031409051 Plastic drumPDF Specification Document
                                  1031409053 Plastic drumPDF Specification Document
                                  1031409100 Plastic drumPDF Specification Document
                                  1031409424 Big BagPDF Specification Document
                                  1031409500 Big BagPDF Specification Document

                                  Certificates

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