| Customization: | Available |
|---|---|
| Appearance: | Colorless, Viscous, Liquid |
| Acidity and Alkalnity: | 4.5-7.5 |
|
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Polyethylene glycol is widely used in various preparations, such as injection, local preparation, eye preparation, oral and rectal preparations.
Polyethylene glycol at the solid level can be added to the liquid polyethylene glycol to adjust the viscosity for local ointments.
Polyethylene glycol mixtures can be used as suppository matrix;
The aqueous solution of polyethylene glycol can be used as a suspension or to adjust the viscosity of other suspension media.
Polyethylene glycol and other emulsifiers are used to increase the stability of emulsion.
In addition, polyethylene glycol is also used as film coating agent, tablet lubricant, controlled release material and so on
| Test items | Analytical methods | Standard | Result | Result found |
| Appearance (25ºC) | Current EP | Clear, viscous, colourless or almost colourless, hygroscopic liquid |
Conforms | Qualified |
| Identification | Current EP | A | Conforms | Qualified |
| Current EP | B | Conforms | Qualified | |
| Current EP | C | Conforms | Qualified | |
| Appearance of solution | Current EP | Meet requirements | Conforms | Qualified |
| Completeness and Color of Solution | Current USP |
Meet requirements |
Conforms |
Qualified |
| Acidity or alkalinity | Current EP | Meet requirements | Conforms | Qualified |
| Acidity and Alkalinity | Current USP | 4 . 5 -7 . 5 | 6.3 | Qualified |
| Average Molecular Weight | Current USP | 5 70- 630 | 594 | Qualified |
| Viscosity(20ºC , mPa · s) | Current EP | 13 .9 -18 . 5 | 17 | Qualified |
| Viscosity(98 .9ºC , cst) | Current USP | 9 .9 -11 .3 | 10.8 | Qualified |
| Hydroxyl value | Current EP | 178 -197 | 189 | Qualified |
| Reducing substances | Current EP | Meet requirements | Conforms | Qualified |
| Freezing point (ºC) | Current EP | 15-25 | 19 | Qualified |
| Ethylene Glycol and Diethylene Glycol (%) | Current USP | ≤0.25 | 0.02 | Qualified |
| Ethylene Glycol and Diethylene Glycol (%) | Current EP | ≤0.4 | 0.02 | Qualified |
| Formaldehyde (ppm) | Current EP | ≤15 | Conforms | Qualified |
| Dioxan( ppm) | Current EP | ≤10 | <2.59 | Qualified |
| 1,4-Dioxane( μg/g) | Current USP | ≤10 | <2.59 | Qualified |
| Water (%) | Current EP | ≤2.0 | 0.07 | Qualified |
| Sulfated ash(%) | Current EP | ≤0.2 | <0.2 | Qualified |
| Residue on Ignition (%) | Current USP | ≤0. 1 | <0.1 | Qualified |
| Solubility | Current USP | Miscible with water, soluble in acetone, in alcohol, in chloroform, in ethylene glycol monoethyl ether, in ethyl acetate and in toluene; insoluble in ether and hexane. |
Conforms | Qualified |
| Specific weight | Current USP | 1. 12 at 25 °C | 1. 1236 | Qualified |
| Heavy Metals (ppm) | Current USP | ≤5 | Conforms | Qualified |
| Residual Solvents | Current USP | Meet requirements | Conforms | Qualified |
| Conclusion | According to Current EP ,Current USP standard, the results meet the requirements. | |||
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