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.
Other requirements— It meets the requirements for Water, Residue on ignition, Heavy metals, and Acid value under Polysorbate 80.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Hong Wang, Ph.D.
Scientist
1-301-816-8351
(EM205) Excipient Monographs 2
USP32–NF27 Page 1319
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.