U.S. PHARMACOPEIA

Search USP29  
Polysorbate 40

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: It responds to 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 89 and 105.
Saponification value 401: between 41 and 52.
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