Macrogol 4000 Powder
USP/NF, EP (Tested for Endotoxin & Microbes)
CAS #:
25322-68-3
Molecular Formula:
HO(C₂H₄O)nH
Synonym:
Polyglycol, Polyethylene oxide
Molecular Weight:
3500 - 4500 g/mol
Overview
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:
- Store at +15°C to +25°C.
- Store in cool, dry conditions in well-sealed containers.
- Protect from humidity and keep away from water.
Pack Sizes: 4 Kg
