Hard Fat
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Tóm tắt nội dung
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Hard Fat is a mixture of glycerides of saturated fatty acids.
2 IMPURITIES
Residue on Ignition 〈281〉: NMT 0.05%
Alkaline Impurities
Sample: 2.0 g
Analysis: Dissolve the Sample 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.
Acceptance criteria: NMT 0.15 mL of 0.01 N hydrochloric acid
3 SPECIFIC TESTS
Melting Range or Temperature, Class II〈741〉: The melting temperature does not differ by more than 2° from the nominal value given in Labeling.
Fats and Fixed Oils, Acid Value〈401〉: NMT 1.0
Fats and Fixed Oils, Hydroxyl Value〈401〉: NMT 70
Fats and Fixed Oils, Iodine Value〈401〉: NMT 7.0
Fats and Fixed Oils, Saponification Value〈401〉: 215–255
Fats and Fixed Oils, Unsaponifiable Matter〈401〉: NMT 3.0%
4 ADDITIONAL REQUIREMENTS
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 27°–44°.

