Polyoxyl Oleate
Polyethylene glycol monooleate [9004-96-0]. » 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 56 or 10 oxyethylene units (nominal values). A suitable antioxidant may be added.
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.
Identification,
Infrared Absorption 197F, on undried specimen.
Acid value 401:
not more than 1.0, determined on 10.0 g.
Hydroxyl value 401
See table below.
Iodine value 401
See table below.
Peroxide value 401:
not more than 12.0.
Saponification value 401
See table below.
Fatty acid composition 401
Polyoxyl Oleate exhibits the following composition profile of fatty acids, as determined in the USP general chapter section Fatty Acid Composition:
Alkalinity
Dissolve 2.0 g of Polyoxyl Oleate in 20 mL of alcohol. To 2 mL of this solution, add 0.05 mL of phenol red TS: the solution is not red.
Total ash 561:
not more than 0.3%, determined on 1.0 g.
Water, Method I 921:
not more than 2.0%.
Limit of free ethylene oxide and dioxane
Proceed as directed for Limit of free ethylene oxide and dioxane under Polyoxyl Stearyl Ether: not more than 1 µg per g of free ethylene oxide is found; and not more than 10 µg per g of dioxane is found.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 1317
Pharmacopeial Forum: Volume No. 29(4) Page 1121
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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