111597 Parteck® SI 400 LEX (Sorbitol)

Overview

Replacement Information

Key Specifications Table

CAS #EC NumberHill FormulaMolar MassGrade Value
50-70-4 200-061-5 C₆H₁₄O₆ 182.17 g/mol Ph Eur,BP,NF,JP

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1115979012
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          Plastic drum 25 kg
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          1115979024
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              Plastic drum 25 kg
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              1.11597.9027
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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)
                  Flash point>100 °C
                  Ignition temperature420 °C
                  Melting Point94 - 96 °C
                  pH value6 - 7 (100 g/l, H₂O, 20 °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
                  WGKNWG not water endangering
                  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
                  StorageStorage temperature: no restrictions.
                  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
                  Pb (Lead)≤ 0.5 ppm
                  Related substances (HPLC, EP) (Major impurity (Mannitol))≤ 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

                  Title

                  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
                  1115979012 Plastic drumPDF Specification Document
                  1115979023 Plastic drumPDF Specification Document
                  1115979024 Plastic drumPDF Specification Document
                  1.11597.9027 Fibre cartonPDF Specification Document

                  Certificates

                  Title

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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