U.S. PHARMACOPEIA

Search USP29  
Polysorbate 60

Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs.
Polyoxyethylene 20 sorbitan monostearate [Compound usually contains also associated fatty acids.] [9005-67-8].
» Polysorbate 60 is a mixture of stearate and palmitate esters of sorbitol and its anhydrides copolymerized with approximately 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides.
Packaging and storage— Preserve in tight containers.
Identification—
A: It meets the requirements for Identification tests A and C under Polysorbate 80.
B: To 2 mL of a solution (1 in 20) add 0.5 mL of bromine TS, dropwise: the bromine is not decolorized (distinction from Polysorbate 80).
Hydroxyl value 401: between 81 and 96.
Saponification value 401: between 45 and 55.
Organic volatile impurities, Method IV 467: meets the requirements. [NOTE—A G16 column has been shown to be an appropriate secondary column.]
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Water, Residue on ignition, Heavy metals, and Acid value under Polysorbate 80.
Auxiliary Information— Staff Liaison : Hong Wang, Ph.D. , Senior Scientific Associate
Expert Committee : (EM205) Excipient Monographs 2
USP29–NF24 Page 3405
Phone Number : 1-301-816-8351