Macrogolglycerol Ricinoleate, EP and Polyoxyl 35 Castor Oil, USP
Cremophor EL is a nonionic solubiliser and emulsifer made by reacting castor oilwith ethylene oxide in a molar ratio o 1 : 35.
The main component o Cremophor EL is glycerol polyethylene glycol ricinoleate. Together with atty acid esters o polyethylene glycol, this orms the hydrophobicpart o the product. The smaller hydrophylic part consists o ree polyethyleneglycols and ethoxylated glycerol.
Cremophor EL is a pale yellow oily liquid that is clear at temperatures above26°C. It has a aint but characteristic odour. The hydrophilic-lipophilic balance (HLB) lies between 12 and 14. The critical micelle concentration (CMC) lies at approx. 0.02%.
Cremophor EL orms clear solutions in water. It is also soluble in many organicsolvents, e.g. ethyl alcohol, n-propyl alcohol, isopropyl alcohol, ethyl acetate,chloroorm, carbon tetrachloride, trichloroethylene, toluene and xylene.In contrast to anionic emulsiying agents, Cremophor EL becomes less soluble inwater at higher temperatures. Thus, aqueous solutions become turbid at a cer-tain temperature.Cremophor EL is miscible with all the other Cremophor grades and, on heating,also with atty acids, atty alcohols and certain animal and vegetable oils. It isthus miscible with oleic and stearic acids, dodecyl and octa-decyl alcohols,castor oil, and a number o lipid-soluble substances.
AppearanceConormsIdentiication Conorms Alkalinity ConormsSaponiication value 65–70 Acid value
2.0% Hydroxyl value 65–78 Iodine value 25–35Water
2.8%pH (10% in water)6–8Ethylene oxide
10 ppmClarity (10% in water) Conorms Colour (10% in water) Max. BY
Density (25°C) 1.05–1.06 g/ml Viscosity (25°C) 700–800 mPa · sSulated ash (USP-NF)
0.2% Ash (Ph. Eur.)
10 ppmResidual solvents(Ph.Eur. 5.4): Only the Class ll solvents, ethylene glycol, and1,4-dioxane, and Class III solvents are likely tobe present. Residual ethylene glycol is below theOption 1 limit o 620 ppm.Residual 1,4-dioxane is below the Option 1 limit o 380 ppm and is separately speciied.Residual Class III solvents are below 0.5%.Microbiological status(Ph.Eur. 5.1.4, Cat. 2 + 3 a)Conorms
MEMP 030711e-04 May 2007Page 2 o 8Cremophor EL