Names and synonyms
USP NF Name
Mixture of hard fat and ethoxylated fatty alcohols
EP Name
Mixture of hard fat and ethoxylated fatty alcohols
UNII Code (FDA)
8334LX7S21 YRC528SWUY
Preferred Substance Name (FDA)
Hard fat Polyoxyl 20 cetostearyl ether
Handbook of Pharmaceutical Excipientsitory bases, hard fat
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Chemical description
Consists of a mixture of mono-, di- and triglyceride esters of fatty acids (C10 to C18), the triester fraction being predominant and ethoxylated fatty alcohols
Key characteristics
Product form
Pellets
Melting range (°C)
32 – 35
Hydroxyl value (mg KOH/g)
40 – 60
Main functionalities
Enables fast-melting at normal temperature of the vaginal cavity.
Main formulation technologies
