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8.17003 SAFC

Polyethylene glycol 400


Synonym: PEG, Poly(ethylene glycol), Polyglycol, Polyethylene oxide, Polyoxy ethylene, PEG 400



Agency/Method   JP
  Ph Eur
Quality Level   500
vapor pressure   <0.1 hPa ( 20 °C)
autoignition temp.   360 °C (DIN 51794)
potency   28000 mg/kg LD50, oral (Rat)
  >20000 mg/kg LD50, skin (Rabbit)
pH   5-7 (20 °C, 100 g/L in H2O)
kinematic viscosity   97-110 cSt(20 °C)
mp   5 °C
transition temp   flash point >200 °C
density   1.13 g/cm3 at 20 °C
SMILES string   C(CO)O
InChI   1S/C2H6O2/c3-1-2-4/h3-4H,1-2H2
storage conditions   Store at +15°C to +25°C.


Analysis Note

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
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 %
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 (*).
Corresponds to Ph Eur, JP

Safety & Documentation

Safety Information

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