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 27 and 44.
and 44.
Melting range, Class II 
741
:
the melting temperature does not differ by more than 2 from the nominal value given under Labeling.
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.
401:
not more than 1.0.
Hydroxyl value 401:
not more than 70.
401:
not more than 70.
Iodine value 401:
not more than 7.0.
401:
not more than 7.0.
Saponification value 401:
between 215 and 255.
401:
between 215 and 255.
Unsaponifiable matter 401:
not more than 3.0%.
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%.
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, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
USP35–NF30 Page 1804