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817003 Polietilena glikol 400

EMPROVE® EXPERT Ph Eur,JP,NF

Polietilena glikol 400 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Polyglycol, Polyethylene oxide, Polyoxy ethylene, PEG 400

CAS #: 25322-68-3 EC Number: 500-038-2 Chemical Formula: HO(C₂H₄O)⁷nH Hill Formula: HO(C₂H₄O)⁷nH Grade: Ph Eur,JP,NF
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817003
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Overview

Replacement Information

Key Spec Table

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

Pricing & Availability

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8170035000
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      		 Wadah plastik 5 l
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      8170039025
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          		 Wadah plastik 25 l
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          8170039220
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              		 Barel plastik 220 kg
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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 20 31
              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 Tikus 28000 mg/kg
              LD 50 dermalLD50 Kelinci > 20000 mg/kg
              Safety Information according to GHS
              RTECSTQ3675000
              Storage class10 - 13 Cairan dan padatan lain
              WGKWGK 1 agak berbahaya untuk air
              Disposal3
              Reagen organik yang relatif tidak aktif harus dikumpulkan dalam kategori A. Jika terhalogenasi, harus ditempatkan dalam Kategori B. Untuk residu padat gunakan Kategori C.
              Safety Information
              Product Usage Statements
              Storage and Shipping Information
              StorageSimpan pada +2°C hingga +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
              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
              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
              8170035000 04022536424163
              8170039025 04022536987156
              8170039220 04022536750088

              Documentation

              Material Qualification Dossier

              TitleVersion
              2.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Polietilena glikol 400 MSDS

              Title

              Safety Data Sheet (SDS) 

              Polietilena glikol 400 Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              8170035000 Wadah plastikPDF Specification Document
              8170039025 Wadah plastikPDF Specification Document
              8170039220 Barel plastikPDF Specification Document

              Certificates

              Title

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              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