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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

Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
1115972500
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      Plastic bottle 2.5 kg
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      1115979012
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          Plastic drum 12 kg
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          1115979024
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              Plastic drum 25 kg
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              1115979028
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                  Fibre carton 25 kg
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                  1115979050
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                      50 kg
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                      1115979500
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                          Big Bag 500 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 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
                          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
                          Global Trade Item Number
                          Catalog Number GTIN
                          1115972500 04027269130848
                          1115979012 04027269138134
                          1115979024 04027269170844
                          1115979028 04022536936468
                          1115979050 04022536133720
                          1115979500 04022536907703

                          Documentation

                          Material Qualification Dossier

                          TitleVersion
                          9.0

                          Quality Management Dossier (Open Access)

                          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
                          1115972500 Plastic bottlePDF Specification Document
                          1115979012 Plastic drumPDF Specification Document
                          1115979024 Plastic drumPDF Specification Document
                          1115979028 Fibre cartonPDF Specification Document
                          1115979050 PDF Specification Document
                          1115979500 Big BagPDF Specification Document

                          Certificates

                          Title

                          Related Products & Applications

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                          Categories

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