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

Leverancier: MERCK PRODUCTION CHEMICALS
Ratings: (No Reviews)

Total Ratings: 0
Avg. Ratings: 0.0 out of 5

Synoniemen: PEG 400

8.17003.5000 8.17003.9220 8.17003.9025
8.17003.5000EA 452 EUR
8.17003.5000 8.17003.9220 8.17003.9025
Polyethylene glycol 400, EMPROVE® ESSENTIAL JP, Ph. Eur. suitable for use as excipient, SAFC®
Polyethylene 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

Formule: H(OCH₂CH₂)nOH
MW: 400 g/mol
Kookpunt: ∼250 °C (1013 hPa)
Smeltpunt: 4…8 °C
Dichtheid: 1.13 g/cm³ (20 °C)
Vlampunt: 245
Bewaar temperatuur: Kamertemperatuur
MDL Nummer: MFCD00081839
CAS nummer: 25322-68-3
EINECS: 500-038-2

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Specification Test Results

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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