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817003 Polyethylene glycol 400

Overview

Replacement Information

Key Specifications Table

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

Products

Catalog NumberPackaging Qty/Pack
8.17003.5000 Plastic container 5 l
8170039025 Plastic container 25 l
8170039220 Plastic barrel 220 kg
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 Rat 28000 mg/kg
LD 50 dermalLD50 Rabbit > 20000 mg/kg
Safety Information according to GHS
RTECSTQ3675000
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
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
StorageStore at +2°C to +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
Catalog Number GTIN
8.17003.5000 04022536424163
8170039025 04022536987156
8170039220 04022536750088

Documentation

Material Qualification Dossier

TitleVersion
2.0

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
8.17003.5000 Plastic containerPDF Specification Document
8170039025 Plastic containerPDF Specification Document
8170039220 Plastic barrelPDF 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 > Liquid Dosage Form > Thickeners
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers