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103140 Parteck® SI 400 (Sorbitol)

EMPROVE® ESSENTIAL Ph Eur,BP,NF,FCC,JSFA,E 420

Parteck® SI 400 (Sorbitol) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: D-Glucitol

CAS #: 50-70-4 EC Number: 200-061-5 Molar Mass: 182.17 g/mol Hill Formula: C₆H₁₄O₆ Grade: Ph Eur,BP,NF,FCC,JSFA,E 420
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103140
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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

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1031402500
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      1031409028
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          1031409053
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              GT11031409028
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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 00
                  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.
                  Global Trade Item Number
                  Catalogue Number GTIN
                  1031402500 04022536961354
                  1031409028 04022536936437
                  1031409053 04054839032981
                  GT11031409028 04061839134560

                  Documentation

                  Material Qualification Dossier

                  TitleVersion
                  8.0

                  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
                  1031409028 Fibre cartonPDF Specification Document
                  1031409053 Plastic drumPDF Specification Document
                  GT11031409028 PDF Specification Document

                  Certificates

                  Title