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Below its melting point of 25°C, polyoxyethanyl-alpha-tocopheryl sebacate is a
yellow-orange wax. Above 25°C, polyoxyethanyl-alpha-tocopheryl sebacate is a
yellow-orange viscous fluid that dissolves in water, alcohols, dichloromethane and
tetrahydrofuran, but not in hexane. Polyoxyethanyl-alpha-tocopheryl sebacate is
hygroscopic and stable at room temperature in aqueous solution.
In GRN 000202, polyoxyethanyl-alpha-tocopheryl sebacate is intended to be used as a
solubilizer for the dietary ingredient coenzyme Q10 (CoQ10) in dietary supplements.
Polyoxyethanyl-alpha-tocopheryl sebacate is manufactured by two consecutive
esterification reactions under anhydrous conditions in ethylacetate with added
triethylamine. Alpha-tocopherol is first linked to sebacoyl dichloride by esterification at its
hydroxy terminus. The resultant alpha-tocopheryl mono-ester of sebacoyl chloride is
subsequently esterified with PEG (molecular weight (mol. wt.) 600) (PEG600) to form
polyoxyethanyl-alpha-tocopheryl sebacate. Polyoxyethanyl-alpha-tocopheryl sebacateis
subsequently purified using acetonitrile and hexane to remove the major impurity,
di-alpha-tocopheryl-sebacate, which is formed as a by-product of sebacoyl chloride
diester formation with alpha-tocopherol.
Zymes, the manufacturer, estimates that the intake of PTS would be limited to 1200
mg/p/day or 20 milligram per kilogram of bodyweight per day (mg/kg bw/day) from the
GRAS Notice No. GRN 000202
SOURCE: FDA website 2010