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817006 Polietilena glikol 4000

(serbuk) EMPROVE® EXPERT Ph Eur,NF

Polietilena glikol 4000 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Polyglycol, Polyethylene oxide, Polyoxy ethylene, PEG 4000

CAS #: 25322-68-3 EC Number: 500-038-2 Molar Mass: 3500 - 4500 g/mol Grade: Ph Eur,NF
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817006
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberMolar MassGrade Value
25322-68-3500-038-23500 - 4500 g/molPh Eur,NF

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8170065000
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      		 Botol plastik 5 kg
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      8170069050
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          		 Karton fiber 50 kg
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          Description
          Catalogue Number817006
          SynonymsPolyglycol, Polyethylene oxide, Polyoxy ethylene, PEG 4000
          References
          Product Information
          CAS number25322-68-3
          EC number500-038-2
          GradePh Eur,NF
          Molar Mass3500 - 4500 g/mol
          HS Code3404 20 20
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Density1.2 g/cm3 (20 °C)
          Flash point138.6 °C
          Ignition temperature>320 °C DIN 51794
          Melting Point57.5 °C
          pH value5 - 7 (100 g/l, H₂O, 20 °C)
          Vapor pressure<0.1 hPa (20 °C)
          Bulk density400 - 500 kg/m3
          Solubility500 g/l
          Dimensions
          Materials Information
          Toxicological Information
          LD 50 oralLD50 Tikus 28000 mg/kg
          LD 50 dermalLD50 Kelinci > 20000 mg/kg
          Safety Information according to GHS
          RTECSTQ4050000
          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
          Identitypasses test
          Appearancewhite or almost white solid with a waxy or paraffin-like appearance
          Appearance of solutionpasses test
          Acidity,Alkalinitypasses test
          Reducing substancespasses test
          pH-value (5 %; water, 25 °C)4.5 - 7.5
          Density (d 20/20)about 1.080 (50% solution)
          Solidification point53 - 59 °C
          Viscosity (20 °C)106 - 131 mm²/s
          Viskosity (20 °C)114 - 142 mPa∙s
          Viscosity 98.9°C (USP-NF)110 - 158 mm²/s
          Formaldehyde≤ 30 ppm
          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 value25 - 32
          Average molecular mass3700 - 4400
          Sulfated ash≤ 0.1 %
          Water (K. F.)≤ 1.0 %
          Endotoxins (Gel-clot-test)≤ 10 I.U./g
          Microbiological test (total aerobic microbial count (TAMC))≤ 100 CFU/g
          Microbiological test (total yeast and mould count (TYMC))≤ 10 CFU/g
          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, USP-NF
          Global Trade Item Number
          Catalogue Number GTIN
          8170065000 04022536424293
          8170069050 04022536704784

          Documentation

          Material Qualification Dossier

          TitleVersion
          4.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Polietilena glikol 4000 MSDS

          Title

          Safety Data Sheet (SDS) 

          Polietilena glikol 4000 Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          8170065000 Botol plastikPDF Specification Document
          8170069050 Karton fiberPDF Specification Document

          Certificates

          Title

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          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 > Solid Dosage Form > Lubricants and Glidants
          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Thickeners
          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers