Purified Stearic Acid
»Purified Stearic Acid is manufactured from fats and oils derived from edible sources and is a mixture of Stearic Acid (C18H36O2)and palmitic acid (C16H32O2),which together constitute not less than 96.0percent of the total content.The content of C18H36O2is not less than 90.0percent of the total.
NOTE—Purified Stearic Acid labeled solely for external use is exempt from the requirement that it be prepared from edible sources.
Packaging and storage—
Preserve in well-closed containers.
Labeling—
If it is for external use only,the labeling so indicates.
and 69
Acid value á401ñ:
between 195and 200,about 1g,accurately weighed,being used.
Iodine value á401ñ:
not more than 1.5.Proceed as directed in Method Iexcept to use 35mLof chloroform.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Other requirements—
It meets the requirements for Residue on ignition,Heavy metals,Mineral acid,Neutral fat or paraffin,and Assayunder Stearic Acid.
Auxiliary Information—
Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3092
Pharmacopeial Forum:Volume No.29(3)Page 706
Phone Number:1-301-816-8262