| Customization: | Available |
|---|---|
| Transport Package: | Pharma Grade PE Bag and Kraft Bag |
| Specification: | 20KG/BAG |
|
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| Test items | Analytical methods | Standard | Result | Result found |
| Appearance (25ºC) | EP | White or almost white solid with a waxy or paraffin-like appearance.Very soluble in water and in methylene chloride,very slightly soluble in ethanol(96 per cent),practically insoluble in fatty oils and in mineral oils | White Powder | Qualified |
| Identification | EP | A | Conforms | Qualified |
| EP | B | Conforms | Qualified | |
| EP | C | Conforms | Qualified | |
| Definition | USP | A qualified | Conforms | Qualified |
| B qualified | Conforms | Qualified | ||
| USP | 97.0-103.0% | 100.2% | Qualified | |
| Appearance of solution | EP | Meet requirements | Conforms | Qualified |
| Completeness and Color of Solution | USP | Meet requirements | Conforms | Qualified |
| Acidity or Alkalinity | EP | Meet requirements | Conforms | Qualified |
| Acidity and Alkalinity | USP | 4.5-7.5 | 5.58 | Qualified |
| Average Molecular Weight | USP | 3015-3685 | 3389 | Qualified |
| Polydispersity | USP | 90%-110% | 101.1% | Qualified |
| Ethylene Glycol | USP | ≤0.062 | ND | Qualified |
| Kinematic viscosity (mm2.S-1) | EP | 76-110 | Conforms | Qualified |
| Freezing point(ºC) | EP | 53-57 | 54 | Qualified |
| Sum of diethylene and ethylene glycol(%) | USP | ≤0.2 | ND | Qualified |
| Sum of Formaldehyde and Acetaldehyde(ug/g) | USP | ≤200 | ND | Qualified |
| Hydroxyl value | EP | 30-38 | 33.1 | Qualified |
| Reducing substances | EP | Meet requirements | Conforms | Qualified |
| Formaldehyde(ppm) | EP | ≤30 | 0.008 | Qualified |
| Formaldehyde(ppm) | USP | ≤30 | ND | Qualified |
| Ethylene oxide(ppm) | EP | ≤1 | ND | Qualified |
| Dioxan(ppm) | EP | ≤10 | ND | Qualified |
| Free Ethylene Oxide(μg/g) | USP | ≤10 | ND | Qualified |
| 1,4-Dioxane(μg/g) | USP | ≤10 | ND | Qualified |
| Water (%) | EP | ≤1.0 | 0.3 | Qualified |
| Sulfated ash(%) | EP | ≤0.2 | 0.08 | Qualified |
| Residue on Ignition(%) | USP | ≤0.1 | 0.08 | Qualified |
| Conclusion | According to the current EP ,current USP standard,the results meet the requirements. | |||
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