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 55.0percent and not more than 63.0percent of fatty acids,and not less than 39.0percent and not more than 45.0percent of polyols (w/w).
Packaging and storage—
Preserve in tight containers.
Identification—
A:
The residue of lauric acid obtained in the Assay for fatty acidshas an acid value (see Fats á401ñ)between 260and 280,about 1g of the residue,accurately weighed,being used,and an iodine value (see Fats and Fixed Oils á401ñ)of not more than 5.
Acid value á401ñ:
not more than 8.
Hydroxyl value á401ñ:
between 330and 358.
Saponification value á401ñ:
between 158and 170.
Water,Method Iá921ñ:
not more than 1.5%.
Residue on ignition á281ñ:
not more than 0.5%.
Heavy metals,Method IIá231ñ:
not more than 0.001%.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay for fatty acids—
Transfer about 10g of Sorbitan Monolaurate,accurately weighed,to a 500-mLconical flask,cautiously add 100mLof alcohol and 3.0g of potassium hydroxide,and mix.Proceed as directed in the Assay for fatty acidsunder Sorbitan Monooleate,beginning with “Connect a suitable condenser.”
Assay for polyols—
Proceed with Sorbitan Monolaurate as directed for Assay for polyolsunder Sorbitan Monooleate.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3083
Phone Number:1-301-816-8330