Polysorbate 60
(pol'' ee sor' bate).

Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs.;    
Polyoxyethylene 20 sorbitan monostearate    
[Compound usually also contains associated fatty acids.]     [9005-67-8].
Polysorbate 60 is a mixture of stearate and palmitate esters of sorbitol and its anhydrides copolymerized with about 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides.
•  A.
Sample solution:  1 in 20, in water
Analysis:  To 5 mL of the Sample solution add 5 mL of sodium hydroxide TS. Boil for a few min, cool, and acidify with 3 N hydrochloric acid.
Acceptance criteria:  The solution is strongly opalescent.
•  B.
Sample solution:  1 in 20, in water
Analysis:  To 2 mL of the Sample solution add 0.5 mL of bromine TS, dropwise.
Acceptance criteria:  The bromine is not decolorized (distinction from polysorbate 80).
•  C. A mixture of 60 volumes of Polysorbate 60 and 40 volumes of water yields a gelatinous mass at normal and lower than normal room temperatures.
•  Residue on Ignition 281: NMT 0.25%
•  Heavy Metals, Method II 231: NMT 10 ppm
•  Acid Value
Sample:  10.0 of Polysorbate 60
Analysis:  Transfer the Sample to a wide-mouth, 250-mL conical flask, and add 50 mL of 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, and add 5 drops of phenolphthalein TS. Titrate with 0.1 N sodium hydroxide VS.
Acceptance criteria:  NMT 4 mL of 0.1 N sodium hydroxide, corresponding to an acid value of 2.2
•  Packaging and Storage: Preserve in tight containers.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Robert H. Lafaver, M.S.
Scientific Liaison
(EXC2010) Monographs - Excipients
USP35–NF30 Page 1920
Pharmacopeial Forum: Volume No. 37(4)