Synonyms | Polysorbate 80 |
Polyoxyethylene (20) sorbitan monooleate |
Definition | A 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 |
Assay | Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis |
Description | A 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 | |
Water | Not more than 3 % (Karl Fischer method) |
Acid value | Not more than 2 |
Saponification value | Not less than 45 and not more than 55 |
Hydroxyl value | Not less than 65 and not more than 80 |
1,4-dioxane | Not more than 5 mg/kg |
Ethylene oxide | Not more than 0,2 mg/kg |
Ethylene glycols (mono- and di-) | Not more than 0,25 % |
Arsenic | Not more than 3 mg/kg |
Lead | Not more than 5 mg/kg |
Mercury | Not more than 1 mg/kg |
Cadmium | Not more than 1 mg/kg |