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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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      1115979024
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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
              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)97.00 - 100.50 %
              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)≤ 5.0000 ppm
              As (Arsenic)≤ 1.00000 ppm
              Ni (Nickel) (#)≤ 1.0000 ppm
              Related substances (HPLC, Ph.Eur) (Major impurities)≤ 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))≤ 200 CFU/g
              Colony count (Yeasts and moulds (TYMC))≤ 100 CFU/g
              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
              # specified acc. to EMEA/CHMP/SWP/4446/2000 (Specification limitsfor residues of metal catalysts or metal reagents). Other residues of metall catalysts or metall reagents acc. to this guidline are not likely to be present.
              corresponds to Ph. Eur., BP, NF, JP
              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
              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