Polyethylene glycol 400, EMPROVE® ESSENTIAL JP, Ph. Eur. suitable for use as excipient, SAFC®
: PEG 400
:25322-68-3
:
:H(OCH₂CH₂)nOH
:MFCD00081839
:∼250 °C (1013 hPa)
:4…8 °C
:1.13 g/cm³ (20 °C)
:400 g/mol
:245
:Ambient
:500-038-2
- Environmentally Preferable:
- 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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