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111597 Parteck® SI 400 LEX (Sorbitol)

Overview

Replacement Information

Key Specifications Table

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

Pricing & Availability

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1115971003
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      1115979023
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          Plastic drum 25 kg
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              Plastic drum 25 kg
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              1.11597.9027
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                  Fibre carton 25 kg
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                  1115979051
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                      50 kg
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                      Description
                      Catalogue Number111597
                      SynonymsD-Glucitol
                      References
                      Product Information
                      CAS number50-70-4
                      EC number200-061-5
                      GradePh Eur,BP,NF,JP
                      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 3 highly 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)≤ 0.006 %
                      Heavy metals (as Pb)≤ 5 ppm
                      As (Arsenic)≤ 1.0 ppm
                      Ni (Nickel) (#)≤ 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 %
                      Residual solvents (ICH Q3C)excluded by manufacturing process
                      Microbiological testpasses test
                      Colony count (aerobic bacteria (TAMC))≤ 10²
                      Colony count (Yeasts and moulds (TYMC))≤ 10²
                      Salmonella spp.in 10g Substance not detectable
                      E.coliin 1g substance not detectable
                      Pseudomonas aeruginosain 1g substance not detectable
                      Staphylococcus aureusin 1g substance not detectable
                      Candida albicansIn 1g substance not detectable
                      Endotoxins≤ 1
                      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, NF, JP
                      corresponds to Ph. Eur., BP, NF, JP

                      Documentation

                      Material Qualification Dossier

                      TitleLot Number
                      1.0

                      Quality Management Dossier

                      Title

                      Operational Excellence Dossier

                      Title

                      Parteck® SI 400 LEX (Sorbitol) SDS

                      Title

                      Safety Data Sheet (SDS) 

                      Parteck® SI 400 LEX (Sorbitol) Certificates of Analysis

                      Product Number PackagingSpecificationLot Number
                      1115971003 Plastic bottlePDF Specification Document
                      1115979023 Plastic drumPDF Specification Document
                      1115979024 Plastic drumPDF Specification Document
                      1.11597.9027 Fibre cartonPDF Specification Document
                      1115979051 PDF Specification Document

                      Certificates

                      Title

                      Related Products & Applications

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                      Categories

                      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
                      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers
                      Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Parteck Excipients > Parteck SI (Sorbitol)
                      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
                      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid