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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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                  1031409100
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                      Plastic drum 100 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

                          TitleLot Number
                          1.0

                          Quality Management Dossier

                          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
                          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
                          1031409100 Plastic drumPDF Specification Document
                          1031409500 Big BagPDF Specification Document

                          Certificates

                          Title