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817002 | Polyethylene glycol 300

817002
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaChemical FormulaGrade Value
      25322-68-3 500-038-2 HO(C₂H₄O)nH HO(C₂H₄O)nH Ph Eur

      Pricing & Availability

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      8.17002.5000
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          Plastic bottle 5 l
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          8170029025
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              Plastic container 25 l
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              Description
              Catalogue Number817002
              SynonymsPolyglycol, Polyethylene oxide, Polyoxy ethylene, PEG 300
              References
              Product Information
              CAS number25322-68-3
              EC number500-038-2
              GradePh Eur
              Hill FormulaHO(C₂H₄O)nH
              Chemical formulaHO(C₂H₄O)nH
              HS Code3907 20 11
              Applications
              ApplicationPolyethylene glycol 300 suitable for use as excipient EMPROVE® exp Ph Eur. CAS 25322-68-3, pH 4 - 7 (100 g/l, H₂O, 20 °C). MSDS and product info below.
              Biological Information
              Physicochemical Information
              Boiling point>220 °C (1013 hPa) decomposes
              Density1.13 g/cm3 (20 °C)
              Flash point220 °C
              Ignition temperature370 °C
              Melting Point-15 - -10 °C
              pH value4 - 7 (100 g/l, H₂O, 20 °C)
              Vapor pressure<0.1 hPa (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
              RTECSTQ3630000
              Storage class10 Combustible liquids not in Storage Class 3
              WGKWGK 1 slightly 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
              Appearanceclear, viscous, colourless or almost colourless hygroscopic liquid
              Identitypasses test
              Appearance of solutionpasses test
              Acidic or alkaline impuritiespasses test
              Density (d 20/20)about 1.120
              Viscosity (20 °C)78.6 - 85.7 mm²/s
              Viskosity (20 °C)88.0 - 96.0 mPa∙s
              Hydroxyl value340 - 394
              Average molecular mass285 - 315
              Reducing substancespasses test
              Formaldehyde≤ 30 ppm
              Ethylene glycol and diethylene glycol≤ 0.4 %
              Ethylene glycol (acc. to ICH-guideline class 2)≤ 620 ppm
              Ethylene oxide (GC)≤ 1 ppm
              Dioxane (GC)≤ 10 ppm
              Heavy metals≤ 20 ppm
              Water (K. F.)≤ 2.0 %
              Sulfated ash≤ 0.2 %
              Other residual solvents acc. to ICH-guideline are excluded by the manufacturing process.
              Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000
              are not likely to be present.
              Corresponds to Ph Eur

              Documentation

              Material Qualification Dossier

              Title

              Quality Management Dossier

              Title

              Operational Excellence Dossier

              Title

              SDS

              Title

              Safety Data Sheet (SDS) 

              Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              8.17002.5000 Plastic bottlePDF Specification Document
              8170029025 Plastic containerPDF Specification Document

              Certificates

              Title

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              Small Molecules Pharmaceutical > Formulation > Liquid Dosage Form > Surfactants and Stabilizers
              Small Molecules Pharmaceutical > Formulation > Semisolid Dosage Form > Surfactants and Stabilizers
              Small Molecules Pharmaceutical > Formulation > Liquid Dosage Form > Solvents
              Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Thickeners
              Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers