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817003 Polyethylene glycol 400

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaChemical FormulaGrade Value
25322-68-3500-038-2HO(C₂H₄O)⁷nHHO(C₂H₄O)⁷nHPh Eur,JP,NF

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8.17003.9025.BWT
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      Plastic container 25 l
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      Description
      Catalogue Number817003
      SynonymsPolyglycol, Polyethylene oxide, Polyoxy ethylene, PEG 400
      References
      Product Information
      CAS number25322-68-3
      EC number500-038-2
      GradePh Eur,JP,NF
      Hill FormulaHO(C₂H₄O)⁷nH
      Chemical formulaHO(C₂H₄O)⁷nH
      HS Code3907 29 11
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density1.116 g/cm3 (975.5 hPa, 20 °C)
      Flash point138.6 °C
      Ignition temperature360 °C DIN 51794
      Melting Point5 °C
      pH value5 - 7 (100 g/l, H₂O, 20 °C)
      Vapor pressure<0.01 hPa (20 °C)
      Viscosity kinematic97 - 110 mm2/s (20 °C)
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat 28000 mg/kg
      LD 50 dermalLD50 Rabbit > 20000 mg/kg
      Safety Information according to GHS
      RTECSTQ3675000
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      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
      Identity (according to JP)passes test
      Identity (according to Ph Eur)passes test
      Appearanceclear, viscous, colourless hygroscopic liquid
      Appearance of solutionpasses test
      Acidity,Alkalinitypasses test
      Acidity (according to JP)passes test
      Reducing substancespasses test
      pH-value (5 %; water, 25 °C)4.5 - 7.0
      Density (d 20/20)1.110 - 1.140
      Viscosity (20 °C)100 - 111 mm²/s
      Viskosity (20 °C)112 - 124 mPa∙s
      Viscosity 98.9°C (USP-NF)6.8 - 8.0 mm²/s
      Formaldehyde≤ 30 ppm
      Ethylene glycol and diethylene glycol≤ 0.25 %
      Ethylene glycol (acc. to ICH-guideline class 2)≤ 620 ppm
      Diethylene glycol≤ 0.10 %
      Ethylene glycol and diethylene glycol (USP-NF)1≤ 0.25 %
      Ethylene oxide (GC)≤ 1 ppm
      Dioxane (GC)≤ 10 ppm
      Ethylene oxide (GC) (USP-NF)1≤ 10 µg/g
      Dioxane (GC) (USP-NF)1≤ 10 µg/g
      Hydroxyl value264 - 300
      Average molecular mass380 - 420
      Sulfated ash≤ 0.1 %
      Water (K. F.)≤ 1.0 %
      Endotoxins (Gel-clot-test)≤ 10 I.U./ml
      Microbiological test (total aerobic microbial count (TAMC))≤ 10²
      Microbiological test (total yeast and mould count (TYMC))≤ 10¹
      Key organismspasses test
      Other residual solvents acc. to ICH-guideline are excluded by the manufacturing process.
      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 (*).
      ¹ measured value from external service laboratory
      Corresponds to Ph Eur, JP, USP-NF
      Global Trade Item Number
      Catalogue Number GTIN
      8.17003.9025.BWT 0

      Documentation

      Material Qualification Dossier

      TitleVersion
      3.1

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Polyethylene glycol 400 SDS

      Title

      Safety Data Sheet (SDS) 

      Polyethylene glycol 400 Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      8.17003.9025.BWT Plastic containerPDF Specification Document

      Certificates

      Title

      Brochure

      Title
      Brochure

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      Categories

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      Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Surfactants and Stabilizers
      Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Ingredients-solid
      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Solvents
      Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Thickeners
      Reagents, Chemicals and Labware > Organic Synthesis > Organic Synthesis Product Groups > Ethers > Hydroxyethers > Glycol Ethers
      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Solvents
      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Thickeners
      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers