Hard Fat
»Hard Fat is a mixture of glycerides of saturated fatty acids.
Packaging and storage—
Preserve in tight containers at a temperature that is 5
or more below the melting range stated in the labeling.
or more below the melting range stated in the labeling.
Labeling—
The labeling includes the nominal melting temperature,which is between 27and 44.
and 44.
Melting range,Class IIá741ñ:
the melting temperature does not differ by more than 2from the nominal value given under Labeling.
from the nominal value given under Labeling.
Acid value á401ñ:
not more than 1.0.
Hydroxyl value á401ñ:
not more than 70.
Iodine value á401ñ:
not more than 7.0.
Saponification value á401ñ:
between 215and 255.
Unsaponifiable matter á401ñ:
not more than 3.0%.
Alkaline impurities—
Dissolve 2.0g in a mixture of 1.5mLof alcohol and 3.0mLof ether.Add 0.05mLof bromophenol blue TS,and titrate with 0.01Nhydrochloric acid to a yellow endpoint:not more than 0.15mLof 0.01Nhydrochloric acid is required.
Residue on ignition á281ñ:
not more than 0.05%.
Auxiliary Information—
Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3006
Phone Number:1-301-816-8262