Names and synonyms
USP NF Name
Hard fat EP/NF/JPE with Glycerol Monostearate EP/NF and PEG-75 Stearate (type I) NF
EP Name
Hard fat EP/NF/JPE with Glycerol monostearate EP/NF and PEG-75 Stearate (type I) NF
UNII Code (FDA)
8334LX7S21 230OU9XXE4 OT38R0N74H
Preferred Substance Name (FDA)
FAT, HARD GLYCERYL MONOSTEARATE PEG-75 STEARATE
Handbook of Pharmaceutical Excipients
Suppository bases, hard fat
Chemical description
Consists of mono-, di- and triglyceride esters of fatty acids (C10 to C18), the triester fraction being predominant and containing glycerol monostearate (C18) and PEG-75 (MW 3500) stearate (C18)
Key characteristics
Product form
Pellets
Melting range (°C)
34.5 – 37.5
Hydroxyl value (mg KOH/g)
40 – 50
Main functionalities
Optimized base for hydrophilic APIs (glycerin), plant extracts, Traditional Chinese Medicines.
Main formulation technologies
