Polysorbate 80
Sorbitan,mono-9-octadecenoate,poly(oxy-1,2-ethanediyl)derivs.,(Z)-.
Polyoxyethylene 20sorbitan monooleate [9005-65-6].
»Polysorbate 80is an oleate ester of sorbitol and its anhydrides copolymerized with approximately 20moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
To 5mLof a solution (1in 20)add 5mLof sodium hydroxide TS.Boil for a few minutes,cool,and acidify with 3Nhydrochloric acid:the solution is strongly opalescent.
B:
To 2mLof a solution (1in 20)add 0.5mLof bromine TS,dropwise:the bromine is decolorized.
C:
Amixture of 60volumes of it and 40volumes of water yields a gelatinous mass at normal and lower than normal room temperatures.
Specific gravity á841ñ:
between 1.06and 1.09.
Viscosity á911ñ:
between 300and 500centistokes when determined at 25
.
.
Acid value—
Weigh 10.0g into a wide-mouth,250-mLconical flask,and add 50mLof neutralized alcohol.Heat on a steam bath nearly to boiling,shaking thoroughly occasionally while heating.Invert a beaker over the mouth of the flask,cool under running water,add 5drops of phenolphthalein TS,and titrate with 0.1Nsodium hydroxide VS:not more than 4mLof 0.100Nsodium hydroxide is required,corresponding to an acid value of 2.2.
Hydroxyl value á401ñ:
between 65and 80.
Saponification value á401ñ:
between 45and 55.
Water,Method Iá921ñ:
not more than 3.0%.
Residue on ignition á281ñ:
not more than 0.25%.
Heavy metals,Method IIá231ñ:
0.001%.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.[NOTE—A G16column has been shown to be an appropriate secondary column.]
Auxiliary Information—
Staff Liaison:Justin Lane,B.S.,Scientific Associate
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3064
Phone Number:1-301-816-8323