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ANNEX IU.K.

E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)U.K.

SynonymsPolysorbate 80
Polyoxyethylene (20) sorbitan monooleate
DefinitionA mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
AssayContent not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
DescriptionA lemon to amber-coloured oily liquid at 25 oC with a faint characteristic odour
Identification
A.Solubility
Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
B.Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
WaterNot more than 3 % (Karl Fischer method)
Acid valueNot more than 2
Saponification valueNot less than 45 and not more than 55
Hydroxyl valueNot less than 65 and not more than 80
1,4-dioxaneNot more than 5 mg/kg
Ethylene oxideNot more than 0,2 mg/kg
Ethylene glycols (mono- and di-)Not more than 0,25 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg