Polyoxyl Oleate
If you find any inaccurate information, please let us know by providing your feedback here
Tóm tắt nội dung
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Polyethylene glycol monooleate
CAS RN®: 9004-96-0.
1 DEFINITION
Polyoxyl Oleate is a mixture of the monoesters and diesters of oleic acid and mixed polyethylene glycols. It may be obtained by ethoxylation of oleic acid or by esterification of polyethylene glycols with oleic acid of animal or vegetable origin. It may contain free polyethylene glycol. The average polymer length is equivalent to either 5–6 or 10 oxyethylene units (nominal values). A suitable antioxidant may be added.
2 IDENTIFICATION
Change to read:
A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197F (CN 1-May-2020)
Sample: Undried specimen
Acceptance criteria: Meets the requirements
3 IMPURITIES
3.1 Limit of Free Ethylene Oxide and Dioxane
Analysis: Proceed as directed in Ethylene Oxide and Dioxane 〈228〉, Method 1.
Acceptance criteria
Ethylene oxide: NMT 1 µg/g
Dioxane: NMT 10 µg/g
4 SPECIFIC TESTS
Fats and Fixed Oils, Acid Value 〈401〉
Sample: 10.0 g
Acceptance criteria: NMT 1.0
Fats and Fixed Oils, Peroxide Value 〈401〉: NMT 12.0
Fats and Fixed Oils, Hydroxyl Value 〈401〉: See Table 1.
Fats and Fixed Oils, Iodine Value 〈401〉: See Table 1.
Fats and Fixed Oils, Saponification Value 〈401〉: See Table 1.
Table 1
| 5-6 Ethylene Oxide Units | 10 Ethylene Oxide Units | |
| Hydroxyl value | 50-70 | 65-90 |
| Iodine value | 50-60 | 27-34 |
| Saponification value | 105-120 | 68-85 |
Fats and Fixed Oils, Fatty Acid Composition 〈401〉: Polyoxyl Oleate exhibits the composition profile of fatty acids shown in Table 2.
Table 2
| Carbon-Chain Length | Number of Double Bonds | Percentage (%) |
| 14 | 0 | ≤5.0 |
| 16 | 0 | ≤16.0 |
| 18 | 0 | ≤6.0 |
| 16 | 1 | ≤8.0 |
| 18 | 1 | 65.0-88.0 |
| 18 | 2 | ≤18.0 |
| 18 | 3 | ≤4.0 |
| >18 | - | ≤4.0 |
Alkalinity
Sample solution: 100 mg/mL of Polyoxyl Oleate in alcohol
Analysis: To 2 mL of the Sample solution add 0.05 mL of phenol red TS.
Acceptance criteria: The solution is not red.
Articles of Botanical Origin, Total Ash 〈561〉
Sample: 1.0 g
Acceptance criteria: NMT 0.3%
Water Determination, Method I 〈921〉: NMT 2.0%
5 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight containers, and store in a cool, dry place. Protect from moisture.
Labeling: Label it to indicate the number of ethylene oxide units per molecule (nominal value), and the name and concentration of any added antioxidant.
USP Reference Standards 〈11〉
USP Polyoxyl Oleate RS
