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115079 Parteck® SI 200 (Sorbitol)

EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF,E 420

Parteck® SI 200 (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,JP,NF,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,JP,NF,E 420

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1150792500
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      		 Plastic bottle 2.5 kg
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      1150799028
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          Description
          Catalogue Number115079
          SynonymsD-Glucitol
          References
          Product Information
          CAS number50-70-4
          EC number200-061-5
          GradePh Eur,BP,JP,NF,E 420
          Hill FormulaC₆H₁₄O₆
          Molar Mass182.17 g/mol
          HS Code2905 44 00
          Quality LevelMQ500
          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
          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
          Appearance of solution (25 %; 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)≤ 0.005 %
          Heavy metals (as Pb)≤ 5 ppm
          As (Arsenic)≤ 1.0 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≤ 2.0 %
          Water≤ 1.5 %
          Particle size (< 100 µm)≤ 15 %
          Particle size (> 200 µm)35 - 70 %
          Particle size (> 500 µm)≤ 6 %
          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 and indicated (#).
          Corresponds to Ph Eur, BP, JP, 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
          1150792500 04027269130855
          1150799028 04022536936475

          Documentation

          Material Qualification Dossier

          TitleVersion
          9.1

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Required Licenses

          Title
          CARTA DE USO GENERAL 2016
          PRODUCTO REGULADO POR OTRAS SECRETARíAS

          Parteck® SI 200 (Sorbitol) SDS

          Title

          Safety Data Sheet (SDS) 

          Parteck® SI 200 (Sorbitol) Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1150792500 Plastic bottlePDF Specification Document
          1150799028 Fibre cartonPDF Specification Document

          Certificates

          Title