A nonionic oil-in-water emulsifier for topical emulsions. It provides excellent emulsion stability with difficult-to-formulate and combination APIs. Provides heat stability and high tolerance over a wide pH range.
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.
SPECIFICATION
