Macrogols (PEG) 400 (EP/USP)
Drug
Code: 125005
For use as excipients in drugs. Can be eaten.
Macrogols (PEG) 400 (EP/USP)
For use as excipients in drugs. Can be eaten.
Cannot sell less than 25kg because the product is EP/USP grade, packaged from EP/USP Certified Facility, cannot be divided into packages.
Usage: Used in medicine only.
Product appearance: liquid
Solubility: Can be dissolved in water directly.
Storage: For long-term storage Store in the refrigerator. Do not expose to sunlight or heat. Seal the lid tightly. Shelf life is at least 2 years.
- Cool (15-25C)
- 24 Months from manufacturing or testing date.
- Please follow instruction under product info carefully.
- Heat Tolerant
- 3.50 - 7.00
- Soluble in Water, Soluble in glycols, Soluble in Ethanol, Soluble in DMSO (Dimethyl Sulfoxide)
- Oral Care
- -
| Test Name | Specification |
|---|---|
| Appearance (25°C) | Clear, viscous, colourless or almost colourless, hygroscopic liquid |
| Identification A | Meet requirements |
| Identification B | Meet requirements |
| Identification C | Meet requirements |
| Appearance of solution | Meet requirements |
| Completeness and Color of Solution | Miscible in water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils |
| Acidity or alkalinity (EP) | Meet requirements |
| Acidity and Alkalinity (USP) | 4.5–7.5 |
| Average Molecular Weight | 380–420 |
| Viscosity (20°C, mPa·s) | 105–130 |
| Viscosity (98.9°C, cst) | 6.8–8.0 |
| Hydroxyl value | 264–300 |
| Reducing substances | Meet requirements |
| Ethylene Glycol and Diethylene Glycol (USP) | ≤0.25 |
| Ethylene Glycol and Diethylene Glycol (EP) | ≤0.4 |
| Formaldehyde (ppm) | ≤15 |
| Ethylene oxide (ppm) | ≤1 |
| Dioxan (ppm) | ≤10 |
| Free Ethylene Oxide (µg/g) | ≤10 |
| 1,4-Dioxane (µg/g) | ≤10 |
| Water (%) | ≤2.0 |
| Sulfated ash (%) | ≤0.2 |
| Residue on Ignition (%) | ≤0.1 |
| Heavy Metals (ppm) | ≤5 |
| TAMC | <10⁴ cfu/ml |
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