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817002 Polyethylenglycol 300 EMPROVE® EXPERT

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaChemical Formula
25322-68-3500-038-2HO(C₂H₄O)⁷nHHO(C₂H₄O)⁷nH

Products

Catalogue NumberPackaging Qty/Pack
8.17002.5000 Plastic container 5 l
8.17002.9025 Plastic container 25 l
Description
Catalogue Number817002
SynonymsPolyglycol, Polyethylene oxide, Polyoxy ethylene, PEG 300
References
Product Information
CAS number25322-68-3
EC number500-038-2
Hill FormulaHO(C₂H₄O)⁷nH
Chemical formulaHO(C₂H₄O)⁷nH
HS Code3907 20 31
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Boiling point>220 °C (1013 hPa) decomposes
Density1.13 g/cm3 (20 °C)
Flash point138.6 °C
Ignition temperature370 °C
Melting Point57.5 °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 - 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
Appearanceclear, viscous, colourless or almost colourless hygroscopic liquid
Appearance of solutionpasses test
Identitypasses test
Acidity,Alkalinitypasses test
Reducing substancespasses test
pH-value (5 %; water, 25 °C)4.5 - 7.5
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
Viscosity 98.9°C (USP-NF)5.4 - 6.4 mm²/s
Ethylene glycol and diethylene glycol≤ 0.4 %
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 value340 - 394
Average molecular mass285 - 315
Formaldehyde≤ 30 ppm
Sulfated ash≤ 0.1 %
Water (K. F.)≤ 2.0 %
Endotoxins (Gel-clot-test)≤ 10 I.U./ml
Microbiological test (total aerobic microbial count (TAMC))≤ 100 CFU/ml
Microbiological test (total yeast and mould count (TYMC))≤ 10 CFU/ml
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
8.17002.5000 04022536424118
8.17002.9025 04022536987149

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Polyethylenglycol 300 EMPROVE® EXPERT SDS

Title

Safety Data Sheet (SDS) 

Polyethylenglycol 300 EMPROVE® EXPERT Certificates of Analysis

Product Number PackagingSpecificationLot Number
8.17002.5000 Plastic containerPDF Specification Document
8.17002.9025 Plastic containerPDF 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 > Thickeners
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Solvents
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers