Polyethylene Glycol 4,000, commonly referred to as PEG 4000, is a polyether compound that is used in a wide variety of fields including pharmaceutical manufacturing as an excipient and active ingredient. Due to its low toxicity it can be used as a lubricating coating for various surfaces in aqueous and non-aqueous environments, a reagent in biochemistry to create very high osmotic pressures, a polar stationary phase for gas chromatography and as a binder.
Characters | Unit | Specification |
---|---|---|
Appearance | white or almost white solid with a waxy or paraffin-like appearance | |
Acidity or alkalinity | ml 0,1M NaOH | max. 0,1 |
Kinematic viscosity (50% solution with density 1,080g/cm³) | mm²/s | 102 – 158 |
Dynamic viscosity (50% solution with density 1,080g/cm³) | mPas | 110 – 170 |
Freezing point | oC | 53 - 59 |
Hydroxyl value (calculated on 14,0g) | 25 - 32 | |
Reducing substances | complies | |
Formaldehyde | ppm | max. 30 |
Ethylen oxide | ppm | max. 1 |
1,4-Dioxane | ppm | max. 10 |
Heavy metals | ppm | max. 20 |
Water | % | max. 2,0 |
Sulphated ash | % | max. 0,2 |
pH value (5% aqu.) | 4,5 – 7,5 | |
Average molecular weight | % | 90,0 – 110,0 |
g/mol | 3600 - 4400 | |
Total aerobic microbial count | cfu/g | max. 100 |
Total yeasts and moulds count | cfu/g | max. 50 |
E.coli | cfu/g | absent in 1g |
Pseudomonas aeruginosa | cfu/g | absent in 1g |
Staphylococcus aureus | cfu/g | absent in 1g |
Salmonella | cfu/g | absent in 25g |
Bacterial endotoxin | I.U./g | max. 10 |
Residual Solvents (Ph. Eur., USP) | According to requirements |
Shelf Life/Retest Date: Macrogol 4000 powder can be kept for at least 2 years if stored under recommended conditions.
Storage/Shipping Conditions:
Pack Sizes: 4 Kg