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111597 Parteck® SI 400 LEX (Sorbitol)

EMPROVE® EXPERT Ph Eur,BP,NF,JP

Parteck® SI 400 LEX (Sorbitol) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: D-Glucitol

CAS #: 50-70-4 EC Number: 200-061-5 Molar Mass: 182.17 g/mol Hill Formula: C₆H₁₄O₆ Grade: Ph Eur,BP,NF,JP
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Overview

Replacement Information

Key Spec Table

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

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      		 Fibre carton 25 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
      Catalogue Number GTIN
      1115979028 04022536936468

      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
      1115979028 Fibre cartonPDF Specification Document

      Certificates

      Title

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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