Names and synonyms
USP NF Name
Mono and Diglycerides and Polyoxyl stearate
EP Name
Glycerol monostearate and macrogol-75 stearate
UNII Code (FDA)
230OU9XXE4 OT38R0N74H
Preferred Substance Name (FDA)
GLYCERYL MONOSTEARATE PEG-75 STEARATE
Handbook of Pharmaceutical Excipients
Glyceryl monostearate Polyoxylethylene stearates
Chemical description
Consists of a mixture of glycerol monostearate and PEG-75 (MW 3500) stearate (C18)
Key characteristics
Product form
Pellets
Melting range
55.5 – 62.5
HLB
10
Main functionalities
Emulsifier for difficult-to-formulate APIs, API combinations, anhydrous emulsion. Associate with Emulcire™ 61 WL2659 to enhance sensorial and texture properties. Safety of use is inferred by precedence of use in approved pharmaceutical products.
Main formulation technologies
Topical emulsion, emulgel, and foam. One-pot formulation process can facilitate manufacturing.
