|
Polysorbate 60
Sorbitan,monooctadecanoate,poly(oxy-1,2-ethanediyl)derivs. Polyoxyethylene 20sorbitan monostearate [Compound usually contains also associated fatty acids.] [9005-67-8]. »Polysorbate 60is a mixture of stearate and palmitate esters 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—
B:
To 2mLof a solution (1in 20)add 0.5mLof bromine TS,dropwise:the bromine is not decolorized (distinction from Polysorbate 80).
Hydroxyl value á401ñ:
between 81and 96.
Saponification value á401ñ:
between 45and 55.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.[NOTE—A G16column has been shown to be an appropriate secondary column.]
Other requirements—
It meets the requirements for Water,Residue on ignition,Heavy metals,and Acid valueunder Polysorbate 80.
Auxiliary Information—
Staff Liaison:Justin Lane,B.S.,Scientific Associate
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3063
Phone Number:1-301-816-8323
|