Polysorbate 80

Sorbitan, mono-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs., (Z)-.
Polyoxyethylene 20 sorbitan monooleate [9005-65-6].
» Polysorbate 80 is an oleate ester 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.
A: To 5 mL of a solution (1 in 20) add 5 mL of sodium hydroxide TS. Boil for a few minutes, cool, and acidify with 3 N hydrochloric acid: the solution is strongly opalescent.
B: To 2 mL of a solution (1 in 20) add 0.5 mL of bromine TS, dropwise: the bromine is decolorized.
C: A mixture of 60 volumes of it and 40 volumes of water yields a gelatinous mass at normal and lower than normal room temperatures.
Specific gravity 841: between 1.06 and 1.09.
Viscosity 911: between 300 and 500 centistokes when determined at 25.
Acid value— Weigh 10.0 g into 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, add 5 drops of phenolphthalein TS, and titrate with 0.1 N sodium hydroxide VS: not more than 4 mL of 0.100 N sodium hydroxide is required, corresponding to an acid value of 2.2.
Hydroxyl value 401: between 65 and 80.
Saponification value 401: between 45 and 55.
Water, Method I 921: not more than 3.0%.
Residue on ignition 281: not more than 0.25%.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Kevin T. Moore, Ph.D.
(EM205) Excipient Monographs 2
USP32–NF27 Page 1320
Pharmacopeial Forum: Volume No. 33(5) Page 1075
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.