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Polysorbate 40
Sorbitan,monohexadecanoate,poly(oxy-1,2-ethanediyl)derivs. Polyoxyethylene 20sorbitan monopalmitate.Compound usually contains also associated fatty acids [9005-66-7]. »Polysorbate 40is a palmitate 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—
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 89and 105.
Saponification value á401ñ:
between 41and 52.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
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
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