U.S. PHARMACOPEIA

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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 96.0 percent of the total content. The content of C18H36O2 is not less than 90.0 percent 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.
Congealing temperature 651: between 66 and 69.
Acid value 401: between 195 and 200, about 1 g, accurately weighed, being used.
Iodine value 401: not more than 1.5. Proceed as directed in Method I except to use 35 mL of chloroform.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Residue on ignition, Heavy metals, Mineral acid, Neutral fat or paraffin, and Assay under Stearic Acid.
Auxiliary Information— Staff Liaison : Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29–NF24 Page 3440
Pharmacopeial Forum : Volume No. 29(3) Page 706
Phone Number : 1-301-816-8262