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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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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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      1031409026
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          1031409028
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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
              1031409026 04022536583501
              1031409028 04022536936437

              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
              1031409026 Plastic sackPDF Specification Document
              1031409028 Fibre cartonPDF Specification Document

              Certificates

              Title