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

Leverandør: MERCK PRODUCTION CHEMICALS
Ratings: Ingen bedømmelse

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Gennemsntilig vurdering

Synonymer: PEG 400

8.17003.5000 8.17003.9220 8.17003.9025
8.17003.5000EA 4270 DKK
8.17003.5000 8.17003.9220 8.17003.9025
Polyethylen glycol 400, EMPROVE® ESSENTIAL JP, Ph. Eur. suitable for use as excipient, SAFC®
Polyethylen glycol 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

Formel: H(OCH₂CH₂)nOH
Molekylvægt: 400 g/mol
Kogepunkt: ∼250 °C (1013 hPa)
Smeltepunkt: 4…8 °C
Massefylde: 1.13 g/cm³ (20 °C)
Flammepunkt: 245
Opbevaringstemperatur: Stue temperatur
MDL Number: MFCD00081839
CAS-nummer: 25322-68-3
EINECS: 500-038-2

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Specifikationer Testresultater

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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