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TPGS Stability & Safety

STABILITY OF VITAMIN E TPGS

Vitamin E TPGS is a highly stable form of vitamin E because the labile (and prone to oxidation) hydroxyl group on the chroman ring of d-α-tocopherol is esterified. It is relatively stable when exposed to oxygen, heat, light, or oxidizing agents. It is unstable to alkali. Vitamin E TPGS is stable under conditions of heat sterilization and repetitive heat/cool/reheat cycles.
Heat Stability Differential Scanning Calorimetry indicates that in lots tested at temperatures well above normal formulation processing temperatures (199 °C) there were no signs of thermal degradation
Flash Point 324 °C
Thermolysis Thermal Decomposition Temperature: No exotherm to 500 °C
Sterilization Differential Scanning Calorimetry shows no thermal degradation when exposed to 125 °C for 1 hour
Shelf Life 4 years (stored at room temperature in the original unopened container)

SAFETY OF VITAMIN E TPGS

Vitamin E TPGS has a record of safety based on decades of clinical trials conducted in animals and humans and on reported toxicology studies. Studies in humans included dosing of cholestatic children at 25 IU/kg/day (equivalent to 64 mg TPGS/kg/day) for over two years. (See References). Or contact us for more information. Vitamin E TPGS is also a safe compound for transportation, storage and handling. For more information please see the Material Safety Data Sheet (MSDS) on the Documentation page.
Oral LD-50 Higher than 7,000 mg/kg in rat (highest dose tested)
Dermal LD-50 ( rat) Higher than 2,000 mg/kg in rat (highest dose tested)
Skin Irritation None (guinea pig)
Eye Irritation Slight (rabbit)
Skin Sensitization None (guinea pig)
No Chlorinated Solvents No chlorinated solvents are used in the manufacture of Antares TPGS