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Sorbitan Monopalmitate
[Graphic formula same as for Sorbitan Monolaurate,except that Ris (C15H31)COO.] Sorbitan,esters,monohexadecanoate. Sorbitan monopalmitate [26266-57-9]. »Sorbitan Monopalmitate is a partial ester of palmitic acid with Sorbitol and its mono-and dianhydrides.It yields,upon saponification,not less than 63.0percent and not more than 71.0percent of fatty acids,and not less than 32.0percent and not more than 38.0percent of polyols (w/w).
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
The residue of palmitic acid obtained in the Assay for fatty acidshas an acid value (see Fats á401ñ)between 210and 225,about 1g of the residue,accurately weighed,being used,and an iodine value (see Fats and Fixed Oils á401ñ)of not more than 4.
Acid value á401ñ:
not more than 8.
Hydroxyl value á401ñ:
between 275and 305.
Saponification value á401ñ:
between 140and 150.
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 IVá467ñ:
meets the requirements.
Assay for fatty acids—
Transfer about 10g of Sorbitan Monopalmitate,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 Monopalmitate 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 3084
Phone Number:1-301-816-8330
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