Polysorbate 40
(pol'' ee sor' bate).
Sorbitan, monohexadecanoate, poly(oxy-1,2-ethanediyl) derivs.
Polyoxyethylene 20 sorbitan monopalmitate. Compound usually contains also associated fatty acids
[9005-66-7].» Polysorbate 40 is a palmitate 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.
Identification—
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 not decolorized (distinction from Polysorbate 80).
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.
Hydroxyl value 
401
:
between 89 and 105.
401:
between 89 and 105.
Saponification value 401:
between 41 and 52.
401:
between 41 and 52.
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.
Water, Method I 921:
not more than 3.0%.
921:
not more than 3.0%.
Residue on ignition 281:
not more than 0.25%.
281:
not more than 0.25%.
Heavy metals, Method II 231:
0.001%.
231:
0.001%.
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 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
USP35–NF30 Page 1919
Pharmacopeial Forum: Volume No. 37(4)