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.
Labeling— The labeling includes the nominal melting temperature, which is between 27 and 44.
Melting range, Class II 741: the melting temperature does not differ by more than 2 from the nominal value given under Labeling.
Acid value 401: not more than 1.0.
Hydroxyl value 401: not more than 70.
Iodine value 401: not more than 7.0.
Saponification value 401: between 215 and 255.
Unsaponifiable matter 401: not more than 3.0%.
Alkaline impurities— Dissolve 2.0 g in a mixture of 1.5 mL of alcohol and 3.0 mL of ether. Add 0.05 mL of bromophenol blue TS, and titrate with 0.01 N hydrochloric acid to a yellow endpoint: not more than 0.15 mL of 0.01 N hydrochloric acid is required.
Residue on ignition 281: not more than 0.05%.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Robert H. Lafaver, B.A.
(EM105) Excipient Monographs 1
USP32–NF27 Page 1237