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Sorbitan Monolaurate
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Sorbitan, esters, monododecanoate.
Sorbitan monolaurate [1338-39-2].
» Sorbitan Monolaurate is a partial ester of lauric acid with Sorbitol and its mono- and dianhydrides. It yields, upon saponification, not less than 55.0 percent and not more than 63.0 percent of fatty acids, and not less than 39.0 percent and not more than 45.0 percent of polyols (w/w).
Packaging and storage— Preserve in tight containers.
Identification—
A: The residue of lauric acid obtained in the Assay for fatty acids has an acid value (see Fats 401) between 260 and 280, about 1 g of the residue, accurately weighed, being used, and an iodine value (see Fats and Fixed Oils 401) of not more than 5.
B: It responds to Identification test B under Sorbitan Monooleate.
Acid value 401: not more than 8.
Hydroxyl value 401: between 330 and 358.
Saponification value 401: between 158 and 170.
Water, Method I 921: not more than 1.5%.
Residue on ignition 281: not more than 0.5%.
Heavy metals, Method II 231: not more than 0.001%.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for fatty acids— Transfer about 10 g of Sorbitan Monolaurate, accurately weighed, to a 500-mL conical flask, cautiously add 100 mL of alcohol and 3.0 g of potassium hydroxide, and mix. Proceed as directed in the Assay for fatty acids under Sorbitan Monooleate, beginning with “Connect a suitable condenser.”
Assay for polyols— Proceed with Sorbitan Monolaurate 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 3429
Phone Number : 1-301-816-8262