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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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              1.11597.9027
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                  Fibre carton 25 kg
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                  1115979050
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                      50 kg
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                      1115979051
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                          50 kg
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                          1115979503
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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 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 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

                              Documentation

                              Material Qualification Dossier

                              TitleLot Number
                              2.0

                              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
                              1115979050 PDF Specification Document
                              1115979051 PDF Specification Document
                              1115979503 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