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Technical data
- Melting Point:
- 55 °C
- Physical Description:
- solid
- Product Code:
- 146224
- Product Name:
- Polyethylene Glycol 8000 (USP-NF, BP, Ph. Eur.) pure, pharma grade
- Quality Name:
- pure, pharma grade
- Specifications:
- Identity according to Pharmacopoeias:: passes test
pH of 5% solution: 4.5-7.5
Freezing point: 55-62°C
Viscosity at 99°C: 470-900 cSt
Viscosity of 50% w/w sol. kinematic 20°C: 240-472 cSt
Viscosity of 50% w/w sol. dynamic 20°C: 260-510 mPa.s
Average molecular weight: 7000-9000
Maximum limit of impurities
Appearance of solution: passes test
Acidity or alkalinity: passes test
Insoluble matter in in H2O: passes test
Reducing substances: passes test
Residue on ignition (as SO4): 0.1 %
Hydroxyl value: 12-16
Residual solvents (Ph.Eur/USP): passes test
1,4-Dioxan (G.C.): 0.001%
Formaldehyde (CH2O): 0.0015%
Ethylene Oxide (G.C.): 0.0001%
Water (H2O): 1 %
Heavy metals (as Pb): 0.0005%
As: 0.0003 %
Elemental impurities according to ICH Q3D guide: No metal catalysts are used in the manufacturing process. Class 1-3 elements are not likely to be present above the limits of ICH Q3D option 1.
- Storage:
- Room Temperature.
- Master Name:
- Polyethylene Glycol 8000
- Synonyms Long Text:
- Carbowax 8000, Macrogol 8000, PEG 8000
- EINECS:
- 203-473-3
- CS:
- 3907 20 11 90