U.S. PHARMACOPEIA

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Sorbitan Trioleate
» Sorbitan Trioleate is the triester of Oleic Acid and Sorbitol and its mono- and dianhydrides. It yields, upon saponification, not less than 85.5 percent and not more than 90.0 percent of fatty acids, and not less than 13.0 percent and not more than 19.0 percent of polyols (w/w).
Packaging and storage— Preserve in tight containers.
Identification— It responds to Identification tests A and B under Sorbitan Monooleate.
Acid value 401: not more than 17.
Hydroxyl value 401: between 50 and 75.
Iodine value 401: between 77 and 85.
Saponification value 401: between 169 and 183.
Water, Method I 921: not more than 0.7%.
Residue on ignition 281: not more than 0.25%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for fatty acids— Transfer about 8.6 g of Sorbitan Trioleate, accurately weighed, to a 500-mL conical flask, cautiously add 100 mL of alcohol and 3.5 g of potassium hydroxide, then add a few glass beads, and mix. Proceed as directed for Assay for fatty acids under Sorbitan Monooleate, beginning with “Connect a suitable condenser.”
Assay for polyols— Proceed as directed for Assay for polyols under Sorbitan Monooleate.
Auxiliary Information— Staff Liaison : Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29–NF24 Page 3431
Phone Number : 1-301-816-8262