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Polyéthylèneglycol 400, EMPROVE® ESSENTIAL JP, Ph. Eur. suitable for use as excipient, SAFC®

Fournisseur: MERCK PRODUCTION CHEMICALS

Synonyms: PEG 400

8.17003.5000 8.17003.9220 8.17003.9025
8.17003.5000EA 421 EUR
8.17003.5000 8.17003.9220 8.17003.9025
Polyéthylèneglycol 400, EMPROVE® ESSENTIAL JP, Ph. Eur. suitable for use as excipient, SAFC®
Polyéthylèneglycol 400

Other residual solvents acc. to ICH-guideline are excluded by the manufacturing process.
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Corresponds to Ph Eur, JP

Formule: H(OCH₂CH₂)nOH
MW: 400 g/mol
Point d'ébullition: ∼250 °C (1013 hPa)
Point de fusion: 4…8 °C
Densité: 1.13 g/cm³ (20 °C)
Point d'éclair: 245
Température de stockage: Température ambiante
Numéro MDL: MFCD00081839
Numéro CAS: 25322-68-3
EINECS: 500-038-2

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Résultats des tests de spécification

Identity (according to JP) passes test
Identity (according to Ph. Eur.) passes test
Appearance clear, viscous, colourless hygroscopic liquid
Appearance of solution passes test
Acidity,Alkalinity passes test
Reducing substances passes test
pH-value (5 %; water, 25 °C) 4.0 - 7.0
Density (d 20/20) 1.110 - 1.140
Viscosity (20 °C) 100 - 111 mm²/s
Viskosity (20 °C) 112 - 124 mPa∙s
Heavy metals ≤ 20 ppm
Formaldehyde ≤ 30 ppm
Ethylene glycol and diethylene glycol ≤ 0.25 %
Ethylene glycol (acc. to ICH-guideline class 2) ≤ 620 ppm
Ethylene oxide (GC) ≤ 1 ppm
Dioxane (GC) ≤ 10 ppm
Hydroxyl value 264 - 300
Average molecular mass 380 - 420
Sulfated ash ≤ 0.1 %
Water (K. F.) ≤ 1.0 %


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