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817006 Polyetylénglykol 4000

Overview

Replacement Information

Key Spec Table

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

Products

Catalogue NumberPackaging Qty/Pack
8170065000 Plastová flaša 5 kg
8170069050 Kartónová krabica 50 kg
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 Potkan 28000 mg/kg
LD 50 dermalLD50 Králik > 20000 mg/kg
Safety Information according to GHS
RTECSTQ4050000
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +2°C až +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

Polyetylénglykol 4000 MSDS

Title

Safety Data Sheet (SDS) 

Polyetylénglykol 4000 Certificates of Analysis

Product Number PackagingSpecificationLot Number
8170065000 Plastová flašaPDF Specification Document
8170069050 Kartónová krabicaPDF Specification Document

Certificates

Title

Brochure

Title
Brochure

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Categories

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