STABILITY

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 maintains its stability when exposed to oxygen, heat, light, or oxidizing agents, including conditions like heat sterilization and repetitive heat/cool/reheat cycles. At a high pH, TPGS undergoes hydrolysis to its constituent molecules.

Heat Stability - Differential Scanning Calorimetry indicates zero signs of thermal degradation, even in samples tested at temperatures well above those experienced during normal formulation processing (199 °C). Vitamin E TPGS also resists thermal degradation in sterilizing conditions, as proven when Differential Scanning Calorimetry showed no degradation when exposed to 125°C for 1 hour.

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 (when stored at room temperature in its original, unopened container)

SAFETY

Vitamin E TPGS has an extensive safety record backed by decades of clinical trials conducted on animals, humans, and published toxicology studies. TPGS can also be safely transported i, stored, and handled with ease.

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

Clinical Evidence - The safety of TPGS has been thoroughly evaluated through studies by the National Cancer Institute and others supported by the National Institutes of Health, the Cystic Fibrosis Foundation, and other research organizations. These studies have assessed the acute and chronic toxicity in two species: reproduction in rats, and developmental toxicity in rodents and rabbits. However, major clinical studies in humans have confirmed its safe use in foods and beverages, dietary supplements, personal care, medical foods, and drug formulations. An extensive review is available in the Opinion of the Scientific Panel European Food Safety Authority (EFSA 2007), which led to its approval for use in foods for special medical purposes.